MODULE 4: Biopharmaceutics and Pharmacokinetics Flashcards

1
Q

It is the ability of a drug to exist in two or more crystalline form

A. Chirality
B. Polymorphism
C. Stereoisomerism
D. A and C
E. None of these

A

Polymorphism

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2
Q

Arrange the following dosage forms from highest to lowest dissolution rate:
I. Solution
II. Capsule
III. Suspension
IV. Tablet

A. I, II, III, IV
B. I, III, II, IV
C. IV, III, II, I
D. IV, II, III, I
E. None of these

A

B. I, III, II, IV

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3
Q

All of the following statements are true regarding particle size of a drug, EXCEPT:

A. Reducing the particle size can decrease the surface area of the molecule exposed to the solvent.
B. Reduction of particle size can be achieved by micronisation using jet mill, spray drying and air attrition
methods.
C. The dissolution of some drugs available in the market has been improved by reducing the particle
size.
D. Reducing the particle size of a drug may increase drug absorption.
E. None of these

A

Reducing the particle size can decrease the surface area of the molecule exposed to the solvent.

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4
Q

Which of the following may increase drug dissolution rate?
I. Too much binder
II. Insoluble diluents
III. High amount of lubricants

A. I only
B. I and II
C. II and III
D. I, II, AND III
E. None of these

A

None of these

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5
Q

Which of the following is not true regarding the purpose of tablet coating?

A. Improves palatability
B. Improve aesthetic value of tablet
C. Improve stability
D. Improve in-vivo degradation
E. None of these

A

Improve in-vivo degradation

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6
Q

A surface active agent that facilitates the absorption of lipophilic drug or water insoluble drugs

A. Bile
B. Albumin
C. Renin
D. Gastric acid
E. None of these

A

Bile

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7
Q

Phase 2 metabolism that protects the body against chemically reactive metabolites

A. Sulfate conjugation
B. Glutathione conjugation
C. Methylation
D. Acetylation
E. Glycine conjugation

A

Glutathione conjugation

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8
Q

All of the following listed below are processes of drug excretion, EXCEPT:

A. Glomerular filtration
B. Active secretion
C. Tubular secretion
D. Tubular reabsorption
E. None of these

A

None of these

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9
Q

It is the basic functional unit of the kidney

A. Glomerulus
B. Loop of henle
C. Nephron
D. Collecting tubule
E. None of these

A

Nephron

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10
Q

Creatinine clearance of a patient with kidney failure

A. 60-89 mL
B. 30-59 mL
C. 15-29 mL
D. <15 mL
E. None of these

A

<15 mL

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11
Q

Which of the following drugs listed below will increase its clearance at alkaline urine?
I. Amphetamine
II. Imipramine
III. Barbiturates
IV. Salicylic acid

A. I and II
B. II and III
C. III and IV
D. All of these
E. None of these

A

C. III and IV

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12
Q

Which of the following correctly describes ion trapping

A. Changing the pH of urine used to facilitate the elimination of drug that proved to be toxic to a patient or has been taken in overdosed amount
B. Administration of acidic drug to neutralize an alkaline poison in the stomach
C. Alkalinizing the urine to facilitate excretion of weakly basic drugs
D. A and C
E. None of these

A

Changing the pH of urine used to facilitate the elimination of drug that proved to be toxic to a patient or has been taken in overdosed amount

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13
Q

Discipline that applies Pharmacokinetic concepts and principles in humans in order to design individualized dosage regimens that optimize the therapeutic response of a medication while minimizing the chance of an adverse drug reaction

A. Clinical toxicology
B. Clinical pharmacy
C. Clinical Pharmacokinetics
D. Pharmacotherapeutics
E. None of these

A

Clinical Pharmacokinetics

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14
Q

Chemical conversion of the drug molecule, usually by an enzymatically mediated reaction, into another chemical entity referred to as a metabolite

A. Absorption
B. Distribution
C. Metabolism
D. Excretion
E. None of these

A

Metabolism

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15
Q

Volume of serum or blood completely cleared of the drug per unit time

A. Volume of distribution
B. Clearance
C. Elimination
D. Plasma concentration
E. None of these

A

Clearance

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16
Q

Hypothetical volume that relates drug serum concentrations to the amount of drug in the body

A. Volume of distribution
B. Clearance
C. Drug Elimination
D. Plasma concentration
E. None of these

A

Volume of distribution

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17
Q

All of the following factors affects the volume of distribution of drug, EXCEPT

A. Volume of blood
B. Size of various organs and tissue in the body
C. Protein binding
D. Physicochemical properties of drug
E. None of these

A

None of these

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18
Q

The fraction of administered dose that is delivered to the systemic circulation is known as the

A. Loading of dose
B. Maintenance dose
C. Bioavailability
D. Active dose
E. None of these

A

Bioavailability

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19
Q

Below is an example of (may pic ata dapat dito?)

A. Dose response curve
B. Plasma level time curve
C. Quantal dose response curve
D. A and B
E. None of these

A

Plasma level time curve

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20
Q

After the first dose of gentamicin is given to a patient with renal failure, the following serum concentrations are obtained:

Time after drug administration(h)
1
24
48

Concentration (mcg/mL)
7.7
5.6
4.0

A. 30 hours and 0.0123/hr
B. 45 hours and 0.0146/hr
C. 55 hours and 0.0129/hr
D. 50 hours and 0.0139/hr
E. None of these

A

50 hours and 0.0139/hr

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21
Q

All of the following are true regarding the rate of drug distribution, EXCEPT:

A. The rate of drug distribution will be faster in highly perfuse tissues
B. The blood brain barrier (BBB) prevents the distribution of many polar compounds in the blood to the brain tissues
C. Only the lipophilic compounds can distribute across BBB by passive diffusion
D. The equilibrium between the drug in the blood and the drug in highly perfused tissues is achieved slower than the equilibrium between the drug in blood and the poorly perfused tissues
E. None of these

A

The equilibrium between the drug in the blood and the drug in highly perfused tissues is achieved slower than the equilibrium between the drug in blood and the poorly perfused tissues

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22
Q

Which of the following factors affect drug distribution?
1. Blood perfusion
2. Tissue composition
3. Plasma protein binding
4 Physicochemical properties of drug

A. 1 only
B. 1 and 2
C. 2 and 3
D. 1, 2, 3, 4
E. None of these

A

D. 1, 2, 3, 4

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23
Q

Technique in the determination of drug plasma protein binding that utilize a special dialysis chamber that is separated into two halves by a semipermeable membrane that allows the transfer of the free drug molecule but not the drug bound to protein.

A. Ultrafiltration
B. Equilibrium dialysis
C. Hemodialysis
D. A and B
E. None of these

A

Equilibrium dialysis

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24
Q

Which of the following statements are true regarding volume of distribution (Vd)?

A. Relates the amount of absorbed drug
with the amount of eliminated drug
B. Total volume of the drug absorbed
C. Drugs that are highly distributed into the tissues have low Vd
D. Drugs that are highly bound to plasma proteins have low Vd
E. All of these

A

Drugs that are highly bound to plasma proteins have low Vd

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25
Q

For nos. 25-29:
A single IV bolus of drug was administered to a patient and the amount of drug in the body was determined at different
time points after drug administration:

Time (h)
0.5, 1, 2, 4, 8, 12

Amount (mg)
396, 315, 198, 79, 12.4, 1.96

Q: What is the order of the elimination process of this drug?

A. Zero order kinetics
B. First order kinetics
C. Second order kinetic
D. A or B
E. None of these

A

First order kinetics

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26
Q

For nos. 25-29:
A single IV bolus of drug was administered to a patient and the amount of drug in the body was determined at different
time points after drug administration:

Time (h)
0.5, 1, 2, 4, 8, 12

Amount (mg)
396, 315, 198, 79, 12.4, 1.96

Q: What is the rate constant for elimination process?

A. 0.5712/hr
B. 0.3789/hr
C. 0.6234/hr
D. 0.4617/hr
E. 0.2341/hr

A

0.4617/hr

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27
Q

For nos. 25-29:
A single IV bolus of drug was administered to a patient and the amount of drug in the body was determined at different
time points after drug administration:

Time (h)
0.5, 1, 2, 4, 8, 12

Amount (mg)
396, 315, 198, 79, 12.4, 1.96

Q: What is the dose of drug administered to this patient?

A. 500 mg
B. 300 mg
C. 200 mg
D. 100 mg
E. 700 mg

A

500 mg

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28
Q

For nos. 25-29:
A single IV bolus of drug was administered to a patient and the amount of drug in the body was determined at different
time points after drug administration:

Time (h)
0.5, 1, 2, 4, 8, 12

Amount (mg)
396, 315, 198, 79, 12.4, 1.96

Q: Calculate the amount of drug in the body 10h after administration

A. 5.32 mg
B. 3.45 mg
C. 4.94 mg
D. 3.22 mg
E. 6.55 mg

A

4.94 mg

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29
Q

For nos. 25-29:
A single IV bolus of drug was administered to a patient and the amount of drug in the body was determined at different
time points after drug administration:

Time (h)
0.5, 1, 2, 4, 8, 12

Amount (mg)
396, 315, 198, 79, 12.4, 1.96

Q: What is the half-life of the drug immediately after drug administration?

A. 3 hrs
B. 5hrs
C. 2.5 hrs
D. 1.5 hrs
E. 3.5 hrs

A

1.5 hrs

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30
Q

For nos. 30-31
The following are the pharmacokinetic parameters for a group of drugs

Drug | Vd (L/Kg) | Elimination rate constant (h-¹)
Theophylline | 0.45 |0.11
Ampicillin | 0.3 | 0.6
Quinidine | 3 | 0.08
Gentamicin | 2 | 0.08
Digoxin | 20 | 0.01

Q: Which drug has the highest Cl?

A. Theophylline
B. Ampicillin
C. Quinidine
D. Gentamicin
E. Digoxin

A

Quinidine

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31
Q

For nos. 30-31
The following are the pharmacokinetic parameters for a group of drugs

Drug | Vd (L/Kg) | Elimination rate constant (h-¹)
Theophylline | 0.45 |0.11
Ampicillin | 0.3 | 0.6
Quinidine | 3 | 0.08
Gentamicin | 2 | 0.08
Digoxin | 20 | 0.01

Q: Which drug has the lowest Cl?
A. Theophylline
B. Ampicillin
C. Quinidine
D. AandB
E. Band C

A

Theophylline

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32
Q

Elimination of a drug refers to:
I. Excretion of unchanged drug in the urine
II. Renal excretion of drug
III. Uptake of a drug from the blood into the liver
IV. Metabolism of drug in the liver
V. Distribution of drug into fat

A. I and II
B. II and III
C. II and IV
D. III and V
E. None of these

A

II and IV

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33
Q

The loading dose of a drug is determined by:
I. Drug clearance
II. Elimination rate
III. Target plasma drug concentration
IV. Volume of distribution
V. Duration of drug effect

A. I and II
B. II and III
C. III and IV
D. IV and V
E. All of these

A

III and IV

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34
Q

Half-life:
I. Increases as the clearance increases
II. Decreases as the volume of distribution increases
III. Decreases as clearance increases
IV. Increases as volume of distribution increases
V. Increases as the elimination rate increases

A. I and II
B. II and III
C. III and IV
D. IV and V
E. None of these

A

III and IV

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35
Q

After a single dose of a drug which has a half-life of 12 hours, what percentage of the dose is still in the body after 1 day?
A. 87.5%
B. 75%
C. 50%
D. 25%
E. 12.5%

A

25%

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36
Q

Which of the following routes of administration completely avoid first pass clearance?
I. Buccal
II. Sublingual
III. Rectal
IV. Oral
V. Transdermal

A. I and II
B. I, II and III
C. I, II and IV
D. I, II and V
E. III and V

A

I, II and V

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37
Q

The term linear pharmacokinetic means:
I. A plot of drug concentration vs. time is linear
II. Half-life increases proportionally with dose
III. A constant amount of drug is eliminated per unit time
IV. Clearance is proportional to the dose
V. Steady state drug concentration is proportional to the dose

A. I only
B. I and II
C. III only
D. II and IV
E. V only

A

V only

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38
Q

Which of the following processes are saturable and can result in non-linear pharmacokinetics?
I. Drug metabolism
II. Glomerular filtration
III. Protein binding
IV. Renal tubular secretion

A. I only
B. II, III, and IV
C. I, II, and IV
D. I, III, and IV
E. None of these

A

I, III and IV

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39
Q
  1. The study of the time course of drug absorption, distribution, metabolism and excretion is called:

A. Pharmacodynamics
B. Drug concentration
C. Pharmacokinetics
D. Kinetics Homogeneity
E. Biopharmaceutics

A

Pharmacokinetics

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40
Q
  1. The application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in and individual patient is known as:

A. Pharmacodynamics
B. Pharmacokinetics
C. Clinical pharmacokinetics
D. Biopharmaceutics
E. None of these

A

Clinical pharmacokinetics

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41
Q

Pharmacodynamics refers to the relationship of drug:

A. Dose to drug concentration in plasma
B. Dose to drug concentration at the receptor site
C. Concentration to drug effect
D. Dose to drug effect
E. None of these

A

Concentration to drug effect

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42
Q

The EC50 refers to the drug concentration at which:

A. One-half the maximum response is achieved.
B. The maximal effect is achieved.
C. Tolerance is likely to be observed.
D. Minimum effective concentration
E. Minimum toxic concentration

A

One-half the maximum response is achieved.

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43
Q

An example of a situation that would not support therapeutic drug concentration monitoring with plasma drug concentrations would be one in which:

A. A wide variation in plasma drug concentrations is achieved in different patients given a standard drug dose.
B. The toxic plasma concentration is many times the therapeutic concentration range.
C. Correlation between a drug’s plasma concentration and therapeutic response is good.
D. A and B
E. B and C

A

The toxic plasma concentration is many times the therapeutic concentration range.

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44
Q

The most commonly used model in clinical pharmacokinetic situations is the:

A. One-compartment model
B. Two-compartment model
C. Multicompartment model
D. A and C
E. All of these

A

One-compartment model

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45
Q

Instantaneous distribution to most body tissues and fluids is assumed in which of the following models?

A. One-compartment model
B. Two-compartment model
C. Multicompartment model
D. A and C
E. All of these

A

One-compartment model

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46
Q

For a drug that has first-order elimination and follows a one-compartment model, which of the following plots would result in a curved line?

A. Plasma concentration versus time
B. Natural log of plasma concentration versus time
C. Common log of plasma concentration versus time
D. A and B
E. B and C

A

Plasma concentration versus time

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47
Q

For the body fluid compartments below, rank them from the lowest volume to the highest, in a typical 70-kg person.

A. Plasma < extracellular fluid < intracellular fluid < total body water
B. Extracellular fluid < intracellular fluid < plasma < total body water
C. Intracellular fluid < extracellular fluid < plasma < total body water
D. Total body water < plasma < intracellular fluid < extracellular fluid
E. None of these

A

Plasma < extracellular fluid < intracellular fluid < total body water

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48
Q

All of the following are true regarding clearance, EXCEPT:
I. The unit for clearance is volume/time
II. Total body clearance is the sum of clearance by the kidneys, liver, and other routes of elimination
III. To determine drug clearance, we must first determine whether a drug best fits one or two compartment model

A. I only
B. II only
C. II and III
D. III only
E. None of these

A

III only

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49
Q

With a drug that follows first-order elimination, the amount of drug eliminated per unit time:

A. Remains constant while the fraction of drug eliminated decreases
B. Decreases while the fraction of drug eliminated remains constant.
C. Increases while the fraction of drug eliminated remains constant.
D. B or C
E. None of these

A

Decreases while the fraction of drug eliminated remains constant.

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50
Q

Which of the following is a proper unit for 1st order elimination rate constant?

A. Minutes
B. mg/minute
C. hr¹
D. mg/L
E. A and B

A

hr¹

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51
Q

Trapezoidal rule method is used in the computation of:

A. K
B. T½
C. AUC
D. Vd
E. Cl

A

AUC

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52
Q

Which of the following are true regarding AUC?
I. Can be used to determine drug clearance
II. Reflects the amount of drug absorbed
III. Dose administered divided by the drug’s clearance

A. I only
B. I and II
C. II and III
D. All of these
E. None of these

A

All of these

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53
Q

Gentamicin has a t½ of:

A. 39 hours
B. 22 hours
C. 7 hours
D. 20 hours
E. 2-3 hours

A

2-3 hours

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54
Q

The time between administration of doses is the:

A. Onset time
B. Dosing range
C. Dosing interval
D. tmax
E. None of these

A

Dosing interval

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55
Q

The point at which the amount of drug administered over a dosing interval equals the amount of drug being eliminated over that same period and is totally dependent on the elimination rate constant:
A. Rate constant
B. Steady state
C. Elimination
D. Absorption phase
E. None of these

A

Steady state

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56
Q

Steady-state concentration can be increase by adjusting which of the following parameters?
I. t½
II. Dose administered
III. Dosing interval

A. I only
B. II only
C. II and III
D. All of these
E. None of these

A

II and III

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57
Q

To predict the plasma concentration of a drug at any time (t) after number of doses (n), we therefore need to know which among the following values?
I. Drug dose
II. Volume of distribution
III. Elimination rate constant
IV. Dosing interval

A. I and II
B. II and III
C. III and IV
D. All of these
E. None of these

A

All of these

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58
Q

This method of giving multiple doses by infusion at specified intervals is called:

A. IV bolus
B. Intermittent IV infusion
C. Multiple infusion
D. A and B
E. None of these

A

Intermittent IV infusion

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59
Q

For a drug regimen, if the elimination rate (K) of a drug is reduced while volume of distribution, drug dose, and dosing interval remain constant, the peak and trough concentrations will:

A. increase
B. decrease
C. remains the same
D. A or B
E. None of these

A

increase

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60
Q

Method used in toxicokinetics and for the extrapolation of therapeutic drug doses in humans from nonclinical animal drug studies.

A. Interspecies scaling
B. Toxicological extrapolation
C. Linear analysis
D. A and C
E. None of these

A

Interspecies scaling

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61
Q

A condition in which glomerular filtration is impaired or reduced, leading to accumulation of excessive fluid and blood nitrogenous products in the body.

A. Cystitis
B. Uremia
C. Pancreatitis
D. Hypovolemia
E. None of these

A

Uremia

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62
Q

Common causes of kidney failure, EXCEPT:
I. Pyelonephritis
II. Hypotension
III. Diabetes mellitus
IV. Nephroallergens

A. I only
B. I and II
C. II only
D. III and IV
E. IV only

A

II only

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63
Q

A fructose polysaccharide used as a standard reference for the measurement of GFR:

A. Chitosan
B. Inulin
C. Cellulose
D. Chitin
E. A and B

A

Inulin

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64
Q

Commonly used clinical diagnostic laboratory test for renal disease

A. Creatinine clearance
B. Measurement of blood urea nitrogen
C. Detection of kidney stone
D. Detection of uric acid in urine
E. None of these

A

Measurement of blood urea nitrogen

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65
Q

The normal blood urea nitrogen for a patient is:

A. 1-10 mg/dL
B. 10-20 mg/dL
C. 20-30 mg/dL
D. 30-40 mg/dL
E. 40-50 mg/dL

A

10-20 mg/dL

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66
Q

Which of the following are true regarding creatinine clearance?
I. Volume of plasma cleared of creatinine per unit time
II. Calculated directly by dividing rate of urinary excretion of creatinine by the patient’s serum creatinine concentration
III. Creatinine clearance is expressed in mL/min and serum creatinine concentration in mg/dL or mg%

A. I only
B. I and II
C. II and III
D. All of these
E. None of these

A

All of these

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67
Q

Stage of kidney disease with creatinine clearance of 30-59 mL/min

A. Stage 1
B. Stage 2
C. Stage 3
D. Stage 4
E. Stage 5

A

Stage 3

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68
Q

Patients with mild decrease in glomerular filtration rate has a creatinine clearance of:

A. > 90 mL/min
B. 60-89 mL/min
C. 30-59 mL/min
D. 15-29 mL/min
E. < 15 mL/min

A

60-89 mL/min

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69
Q

An artificial process in which the accumulation of drugs or waste metabolites is removed by diffusion from the body into the specialized fluid

A. Dialysis
B. Hemodiffusion
C. Ultrafiltration
D. A and C
E. None of these

A

Dialysis

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70
Q

Uses a dialysis machine and filters blood through an artificial membrane. It requires access to the blood vessels to allow the blood to flow to the dialysis machine and back to the body.

A. Hemodialysis
B. Peritoneal dialysis
C. Continuous ambulatory peritoneal dialysis
D. Hemoperfusion
E. Hemofiltration

A

Hemodialysis

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71
Q

The process of removing drug by passing the blood from the patient through an adsorbent material and back to the patient:

A. Hemodialysis
B. Peritoneal dialysis
C. Continuous ambulatory peritoneal dialysis
D. Hemoperfusion
E. Hemofiltration

A

Hemoperfusion

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72
Q

A process by which fluids, electrolytes, and small molecular weight substances are removed from the blood by means of low pressure flow through hollow artificial fibers or flat plate membranes

A. Hemodialysis
B. Peritoneal dialysis
C. Continuous ambulatory peritoneal dialysis
D. Hemoperfusion
E. Hemofiltration

A

Hemofiltration

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73
Q

Which of the following are true regarding dosing consideration on patients with hepatic impairments?
I. All liver diseases affect the pharmacokinetics of the drugs to the same extent
II. Drug-protein binding may be altered due to attention in hepatic synthesis of albumin.
III. Metabolism of drugs with high intrinsic clearance may be impaired.
IV. Drugs with a wide therapeutic range will be less affected by moderate hepatic impairment.

A. I, II and III
B. II, III and IV
C. I, II and IV
D. All of these
E. None of these

A

II, III and IV

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74
Q

Hepatic metabolic marker found in liver and many other tissues, including cardiac and skeletal muscles:

A. ALT
B. ALP
C. AST
D. SGPT
E. A and D

A

AST

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75
Q

Hepatic metabolic marker that is only specific on liver:

A. ALT
B. ALP
C. AST
D. SGPT
E. A and D

A

A and D

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76
Q

Patients having liver disease have the following pharmacokinetic characteristics except:

A. Increase drug protein binding
B. Decreased drug metabolism
C. Increase drug half-life
D. Increase Vd for hydrophilic drugs
E. None of these

A

Increase drug protein binding

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77
Q

Pregnancy category wherein there is a positive evidence of risk in taking the drug but the benefit in taking the drug outweighs the risk.

A. Category A
B. Category B
C. Category C
D. Category D
E. Category X

A

Category D

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78
Q

Pharmacokinetic behavior of geriatric patients:
I. Impaired absorption
II. Slow metabolism
III. Prolonged drug half-life

A. I only
B. I and II
C. II and III
D. All of these
E. None of these

A

All of these

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79
Q

All of the following are true regarding capacity limited excretion, EXCEPT:

A. Passive secretion and passive reabsorption
B. Saturated tubular secretion decreases ClR
C. Saturated tubular reabsorption increases ClR
D. A and B are saturable processes
E. None of these

A

Passive secretion and passive reabsorption

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80
Q

Example of a drug that exhibits saturable protein binding:
I. Nicardipine
II. Propranolol
III. Amoxicillin

A. I only
B. I and II
C. II and III
D. All of these
E. None of these

A

I and II

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81
Q

The following parameters listed below can be adjusted when designing a multiple dosage regimen except:

A. Size of dose administered
B. Drug protein binding
C. Dosing interval
D. All of these
E. None of these

A

Drug protein binding

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82
Q

The initial step in the elimination process via the kidney occurs in the:

A. Glomerulus
B. Nephron
C. Distal Tubule
D. Proximal tubule
E. None of these

A

Glomerulus

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83
Q

The capacity of the body to eliminate the drug after it has reached the general circulation is reflected by the:

A. Total clearance
B. Volume of distribution
C. Biliary recycling
D. AUC
E. None of these

A

Total clearance

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84
Q

The process of drug metabolism and excretion constitute:

A. Deposition
B. Elimination
C. Accumulation
D. Biotransformation
E. Clearance

A

Elimination

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85
Q

True about enzyme induction:
I. Low therapeutic levels of active drug (decrease drug efficacy)
II. Prodrug (decrease in efficacy)
III. Toxic metabolite (decrease in toxicity)

A. I only
B. I and II
C. II and III
D. IV only
E. None of these

A

I only

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86
Q

Which of the following enzyme(s) is/are utilized in Phase I Metabolism?
I. CYP3A4
II. UDP glucuronosyl acyltransferase
III. N-acetyltransferase

A. I only
B. I and II
C. II and III
D. I and III
E. All of these

A

I only

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87
Q

Which of the following enzyme(s) is/are utilized in Phase II Metabolism?
I. CYP3A4
II. UDP glucuronosyl acyltransferase
III. N-acetyltransferase

A. I only
B. I and II
C. II and III
D. I and III
E. All of these

A

II and III

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88
Q

A lipophilic medicinal agent has the following property:

A. Low ability to penetrate through the cell membrane lipids
B. Penetrate through membranes by means of endocytosis
C. Low permeation through the blood-brain barrier
D. High reabsorption in renal tubules
E. None of these

A

High reabsorption in renal tubules

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89
Q

The plasma level time curve below follows what compartment model?

A. One compartment
B. Two compartment
C. Three compartment
D. A or B
E. None of these

A

One compartment

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90
Q

Two compartment model:
I. Resolves the body into central and peripheral compartment
II. Peripheral compartment is composed of less perfused organs muscle, fat and lungs.
III. The difference from one compartment model is that the drug does achieve instantaneous distribution.

A. I only
B. I and II
C. II and III
D. I and III
E. All of these

A

I only

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91
Q

The drug achieves instantaneous distribution throughout the body and the drug equilibrates instantaneously between the tissues.

A. Nonlinear pharmacokinetics
B. One-compartment model
C. Two-compartment model
D. A or C
E. None of these

A

One-compartment model

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92
Q

Drug Clearance:
I. A measure of drug elimination from the body
II. Drug clearance refers to the volume of plasma fluid that is cleared of drug per unit
III. Clearance may also be considered as the fraction of drug removed per unit time
multiplied by the rate constant

A. I only
B. I and II
C. II and III
D. I and III
E. None of these

A

I and II

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93
Q

Volume of distribution:
I. The theoretical volume that would be necessary to contain the total amount of an administered drug at the same concentration that is observed in the plasma
II. Indicator of the extent of drug distribution into body fluids and tissues
III. Important in calculation of drug dose

A. I only
B. I and II
C. II and III
D. I and III
E. All of these

A

All of these

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94
Q

Determine the half-life of an antihypertensive drug if it appears to be eliminated from the body at a rate constant of 0.07/hr. Assume first-order kinetics occurs.

A. 12 hours
B. 9.9 hours
C. 7 hours
D. 4 hours
E. 1.5 hours

A

9.9 hours

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95
Q

The amount of drug A is decreasing at a rate that is proportional to the amount of drug A

A. Non-linear pharmacokinetics
B. 1st order
C. Zero order
D. Enzyme kinetics
E. B or C

A

1st order

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96
Q

Procedures employing test apparatus and equipment without involving laboratory animals or humans.

A. In-vivo
B. In-silico
C. In-vitro
D. Ex-vivo
E. All of these

A

In-vitro

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97
Q

Release of the drug substance from the drug product either for local drug action or for drug absorption into the plasma for systemic therapeutic activity

A. Drug product performance
B. Pharmacokinetics
C. Biopharmaceutics
D. Pharmacodynamics
E. A and B

A

Drug product performance

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98
Q

Biopharmaceutics examines the interrelationship of the following, EXCEPT:
I. Physical/chemical properties of the drug
II. The dosage form (drug product) in which the drug is given
III. Route of administration
IV. Rate and extent of systemic drug absorption.

A. I only
B. II only
C. II and III
D. IV only
E. None of these

A

None of these

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99
Q

Oral, topical, parenteral, transdermal, inhalation are examples of:

A. Dosage form
B. Route of administration
C. Therapeutic effect
D. A and B
E. None of these

A

Route of administration

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100
Q

Application of pharmacokinetic principles to the design, conduct and interpretation of drug safety evaluation studies and in validating dose related exposure in animals.

A. Toxicokinetics
B. Biopharmaceutics
C. Pharmacodynamics
D. Pharmacokinetics
E. A and B

A

Toxicokinetics

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101
Q

Include sampling blood, spinal fluid, synovial fluid, tissue biopsy, or any biologic material that requires parenteral or surgical intervention in the patient.

A. In-vitro methods
B. Invasive methods
C. Non-invasive methods
D. Ex-vivo methods
E. None of these

A

Invasive methods

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102
Q

Include sampling of urine, saliva, feces, expired air, or any biologic material that can be obtained without parenteral or surgical intervention.

A. In-vitro methods
B. Invasive methods
C. Non-invasive methods
D. Ex-vivo methods
E. None of these

A

Non-invasive methods

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103
Q

The noncellular liquid fraction of whole blood and contains all the proteins including albumin

A. Platelet
B. Serum
C. Plasma
D. Fibrin
E. None of these

A

Plasma

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104
Q

Liquid obtained from whole blood after the blood is allowed to clot and the clot is removed. Does not contain the cellulr elements, fibrinogen, or the other clotting factors from the blood.

A. Platelet
B. Serum
C. Plasma
D. Fibrin
E. None of these

A

Serum

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105
Q

Indicate the part of a plasma level-time curve
(NOTE: SAME QUES, DIFF ANS. FROM NO’S 105-111. IDK WHY)

A. tmax
B. Therapeutic range
C. Cmax
D. MEC
E. MTC

A

Therapeutic range

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106
Q

Indicate the part of a plasma level-time curve
(NOTE: SAME QUES, DIFF ANS. FROM NO’S 105-111. IDK WHY)

A. Cmax
B. tmax
C. Onset time
D. AUC
E. Therapeutic range

A

Cmax

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107
Q

Indicate the part of a plasma level-time curve
(NOTE: SAME QUES, DIFF ANS. FROM NO’S 105-111. IDK WHY)

A. Duration of action
B. Onset time
C. MEC
D. MTC
E. tmax

A

Duration of action

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108
Q

Indicate the part of a plasma level-time curve
(NOTE: SAME QUES, DIFF ANS. FROM NO’S 105-111. IDK WHY)

A. Duration of action
B. Onset time
C. MEC
D. MTC
E. tmax

A

MEC

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109
Q

Indicate the part of a plasma level-time curve
(NOTE: SAME QUES, DIFF ANS. FROM NO’S 105-111. IDK WHY)

A. Cmax
B. tmax
C. MEC
D. MTC
E. AUC

A

MTC

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110
Q

Indicate the part of a plasma level-time curve
(NOTE: SAME QUES, DIFF ANS. FROM NO’S 105-111. IDK WHY)

A. tmax
B. Cmax
C. Onset time
D. Duration of action
E. MEC

A

Onset time

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111
Q

Indicate the part of a plasma level-time curve
(NOTE: SAME QUES, DIFF ANS. FROM NO’S 105-111. IDK WHY)

A. tmax
B. Cmax
C. Onset time
D. MTC
E. MEC

A

tmax

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112
Q

Difference between the onset time and the time for the drug to decline back to the MEC.

A. Duration of action
B. Onset time
C. AUC
D. Cmax
E. MTC

A

Duration of action

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113
Q

Corresponds to the time required for the drug to reach the MEC

A. Duration of action
B. Onset time
C. AUC
D. Cmax
E. MTC

A

Onset time

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114
Q

The plasma level time curve below portrays a drug that is administered in what route of administration?

A. IV bolus
B. Oral
C. IV infusion
D. Intramuscular
E. None of these

A

Oral

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115
Q

Presence of drug in this sample may reflect drug that has not been absorbed after an oral dose or may reflect drug that has been expelled by biliary secretion after systemic absorption.

A. Feces
B. Urine
C. Saliva
D. Milk
E. Sweat

A

Urine

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116
Q

Which of the following are functions of pharmacokinetic models?
I. Predict plasma, tissue, and urine drug levels with any dosage regimen
II. Calculate the optimum dosage regimen for each patient individually
III. Evaluate differences in the rate or extent of availability between formulations

A. I only
B. I and II
C. II and III
D. All of these
E. None of these

A

All of these

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117
Q

Unit for zero order rate constant:

A. Concentration/time
B. Drug/volume
C. Volume/time
D. Concentration x time
E. 1/time

A

Concentration/time

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118
Q

Unit for clearance:

A. Concentration/time
B. Drug/volume
C. Volume/time
D. Concentration x time
E. 1/time

A

Volume/time

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119
Q

Unit for plasma drug concentration

A. Concentration/time
B. Drug/volume
C. Volume/time
D. Concentration x time
E. 1/time

A

Drug/volume

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120
Q

Unit for area under the curve

A. Concentration/time
B. Drug/volume
C. Volume/time
D. Concentration x time
E. 1/time

A

Concentration x time

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121
Q

Unit for 1st order rate constant:

A. Concentration/time
B. Drug/volume
C. Volume/time
D. Concentration x time
E. 1/time

A

1/time

122
Q

All of the following are included in the peripheral compartment/tissue compartment, EXCEPT:
I. Fat
II. Muscle
III. Cerebrospinal fluid
IV. Plasma

A. I and II
B. II only
C. III and IV
D. IV only
E. None of these

A

IV only

123
Q

The curve that represents the initial, more rapid decline of drug from the central compartment into the tissue compartment as seen in the plasma level time curve below is:

A. Absorption phase
B. Distribution phase
C. Excretion phase
D. Metabolism phase
E. Elimination phase

A

Distribution phase

124
Q

The pharmacokinetics of a drug given by constant IV infusion follows what input process?

A. Zero order
B. 1st order
C. 2nd order
D. A or B
E. None of these

A

Zero order

125
Q

Constant IV drug infusion are considered to have zero order drug absorption because of the direct input. Once the drug is infused, most of the drug is eliminated by first order elimination.

A. Only the 1st statement is correct
B. Only the 2nd statement is correct
C. Both statement is incorrect
D. Both statement is correct
E. Cannot determine the validity

A

Both statement is correct

126
Q

Drug elimination is usually divided into two major components: excretion and biotransformation. Drug excretion is the removal of the interact drug.

A. Only the 1st statement is correct
B. Only the 2nd statement is correct
C. Both statement is incorrect
D. Both statement is correct
E. Cannot determine the validity

A

Both statement is correct

127
Q

Nonvolatile and polar drugs are excreted mainly by renal excretion. Volatile drugs, such as gaseous anesthetics, alcohol or drugs with high volatility, are excreted via the lungs into expired air.

A. Only the 1st statement is correct
B. Only the 2nd statement is correct
C. Both statement is incorrect
D. Both statement is correct
E. Cannot determine the validity

A

Both statement is correct

128
Q

Biotransformation is the process by which the drug is chemically converted in the body to a metabolite. Other name for drug biotransformation is drug elimination.

A. Only the 1st statement is correct
B. Only the 2nd statement is correct
C. Both statement is incorrect
D. Both statement is correct
E. Cannot determine the validity

A

Only the 1st statement is correct

129
Q

The two major drug eliminating organs in the body:
I. Heart
II. Lungs
III. Liver
IV. Kidney

A. I and II
B. II and III
C. III and IV
D. I and IV
E. I and III

A

III and IV

130
Q

Major route of elimination for many drugs:

A. Renal excretion
B. Biliary excretion
C. Fecal excretion
D. B and C
E. None of these

A

Renal excretion

131
Q

The processes by which a drug is excreted via the kidneys may include any combination of the following listed below, EXCEPT:
I. Glomerular filtration
II. Active tubular secretion
III. Passive secretion
IV. Tubular reabsorption

A. I only
B. I and II
C. II only
D. II and III
E. III only

A

III only

132
Q

Unidirectional drug excretion process that occurs for most small molecules (MW < 500), including nonionized and ionized drugs.

A. Glomerular filtration
B. Active tubular secretion
C. Tubular reabsorption
D. Enterohepatic recycling
E. None of these

A

Glomerular filtration

133
Q

A carrier mediated system that requires energy input, because the drug is transported against a concentration gradient.

A. Glomerular filtration
B. Active tubular secretion
C. Tubular reabsorption
D. Enterohepatic recycling
E. None of these

A

Active tubular secretion

134
Q

Occurs after the drug is filtered through the glomerulus and can be an active or passive involving transporting back of the drug into the plasma:

A. Glomerular filtration
B. Active tubular secretion
C. Tubular reabsorption
D. Enterohepatic recycling
E. None of these

A

Tubular reabsorption

135
Q

All of the following listed below are characteristics of active tubular secretion process, EXCEPT:
I. Carrier mediated system that requires energy input
II. Drugs with similar structures may compete for the same carrier system
III. It can be a passive process

A. I only
B. I and II
C. II and III
D. III only
E. None of these

A

None of these

136
Q

Active tubular secretion happens in this part of kidney:

A. Glomerulus
B. Proximal tubule
C. Distal tubule
D. Collecting Duct
E. None of these

A

Proximal tubule

137
Q

Tubular reabsorption happens in this part of kidney:

A. Glomerulus
B. Proximal tubule
C. Distal tubule
D. Collecting Duct
E. None of these

A

Distal tubule

138
Q

Which renal elimination processes are influenced by protein binding?

A. Glomerular filtration
B. Active tubular secretion
C. Tubular reabsorption
D. Enterohepatic recycling
E. None of these

A

Glomerular filtration

139
Q

Which renal elimination processes are influenced by urinary pH?

A. Glomerular filtration
B. Active tubular secretion
C. Tubular reabsorption
D. Enterohepatic recycling
E. None of these

A

Tubular reabsorption

140
Q

Which renal elimination processes are influenced by competitive inhibitors?
A. Glomerular filtration
B. Active tubular secretion
C. Tubular reabsorption
D. Enterohepatic recycling
E. None of these

A

Active tubular secretion

141
Q

[For nos. 141-145]
JPT is a 35-year-old male weighing 80 kg. The patient is to be given multiple IV bolus injections of an antibiotic every 6hours. This effective concentration of this drug is 16 mcg/mL. After the patient is given a single IV dose, the elimination half-life for the drug is determined to be 3.0 hr and the apparent VD is 196 mL/kg.

Determine a multiple IV dose regimen for this drug.

A. 255 mg every 6 hours
B. 360 mg every 6 hours
C. 362 mg every 6 hours
D. 348 mg every 6 hours
E. 445 mg every 6 hours

A

445 mg every 6 hours

142
Q

[For nos. 141-145]
Assume that the antibiotic is 90% bioavailable and that the physician would like to continue oral medication every 6 hours. Determine the multiple oral dose regimen:

A. 386 mg every 6 hours
B. 252 mg every 6 hours
C. 198 mg every 6 hours
D. 333 mg every 6 hours
E. 401 mg every 6 hours

A

386 mg every 6 hours

143
Q

[For nos. 141-145]
Assume that the antibiotic is available in 125-, 250-, and 500-mg tablets. The pharmacist decide to dispense 125 mg tablet and 250-mg tablet. What is the new plasma drug concentration if the patient is given 375 mg every 6 hours? (Bioavailability of drug in tablet form - 90%)

A. 16.12 mcg/mL
B. 14.4 mcg/mL
C. 25.39 mcg/mL
D. 15.53 mcg/mL
E. 18.11 mcg/mL

A

15.53 mcg/mL

144
Q

[For nos. 141-145]
What is the new drug plasma concentration if the patient takes a 500-mg dose every 6 hours?

A. 20.71 mcg/mL
B. 19.2 mcg/mL
C. 18.19 mcg/mL
D. 21.12 mcg/mL
E. 15.98 mcg/mL

A

idk why wala sagot

145
Q

[For nos. 141-145]
What is the drug plasma concentration if a patient follows a dosage regimen of 500 mg tablet every 8 hours?
A. 16.12 mcg/mL
B. 14.4 mcg/mL
C. 25.39 mcg/mL
D. 15.53 mcg/mL
E. 18.11 mcg/mL

A

15.53 mcg/mL

146
Q

The purpose of giving a loading dose is to achieve desired plasma concentrations as quickly as possible. For a drug with long elimination half-life, it may take a long time to achieve steady state levels.

A. Only the 1st statement is correct
B. Only the 2nd statement is correct
C. Both statement is incorrect
D. Both statement is correct
E. Cannot determine the validity

A

Both statement is correct

147
Q

When several doses are administered for a drug with linear kinetics, drug accumulation may occur according to the principle of superposition. The principle of superposition is used to examine the effect of an early, late, or missing dose on steady state drug concentration.

A. Only the 1st statement is correct
B. Only the 2nd statement is correct
C. Both statement is incorrect
D. Both statement is correct
E. Cannot determine the validity

A

Both statement is correct

148
Q

The physician wants the patient to take medication every 6 hours. What dose of theophylline would you recommend (assume theophylline is 100% bioavailable)?

A. 289 mg
B. 343 mg
C. 315 mg
D. 256 mg
E. 450 mg

A

343 mg

149
Q

If you were to find that theophylline is available in 225mg capsules only, what dosage regimen would you recommend?

A. 225 mg every 3 hours
B. 225 mg every 4 hours
C. 225 mg every 5 hours
D. 225 mg every 6 hours
E. 225 mg every 7 hours

A

225 mg every 4 hours

150
Q

Example of a drugs that undergo nonlinear pharmacokinetics thru saturable plasma protein binding:
I. Phenylbutazone
II. Warfarin
III. Levodopa
IV. Riboflavin

A. I only
B. I and II
C. II and III
D. III and IV
E. IV only

A

I and II

151
Q

Example of a drugs that undergo nonlinear pharmacokinetics thru saturable transport in GUT wall:
I. Phenylbutazone
II. Warfarin
III. Levodopa
IV. Riboflavin

A. I only
B. I and II
C. II and III
D. III and IV
E. IV only

A

III and IV

152
Q

Drugs that demonstrate saturation kinetics usually shiw which of the following characteristics?
I. Elimination of drug does not follow simple first order kinetics
II. Elimination kinetics are linear
III. The area under the curve is not proportional to tge amount
IV. The elimination of half-life does not change as dose is increased.

A. I only
B. I and III
C. II and III
D. II and III
E. I and IV

A

I and III

153
Q

Refers to a noncyclical change in the drug absorption or drug eliminationrate process over a period of time.

A. Chronopharmacokinetics
B. Time-dependent pharmacokinetics
C. Product inhibition
D. Linear pharmacokinetics
E. A or B

A

Time-dependent pharmacokinetics

154
Q

For a 70 kg male patient, the approximate volume of extracellular water is:

A. 27 L
B. 15 L
C. 12 L
D. 5 L
E. 1 L

A

15 L

155
Q

For a 70 kg male patient, the approximate volume of intracellular water is:

A. 27 L
B. 15 L
C. 12 L
D. 5 L
E. 1 L

A

27 L

156
Q

Represents the pressure gradient between the arterial end of the capillaries entering the tissue and the venous capillaries leaving the tissue.

A. Osmotic pressure
B. Concentration gradient
C. Hydrostatic pressure
D. Arterial pressure
E. Venous pressure

A

Hydrostatic pressure

157
Q

Which of the following human tissues receives the highest blood flow?

A. Kidney
B. Heart
C. Brain
D. Fat
E. Muscle

A

Kidney

158
Q

Which of the following human tissues receives the least blood flow?

A. Kidney
B. Heart
C. Brain
D. Fat
E. Muscle

A

Fat

159
Q

Physical property that measures the ratio of the solubility of the drug in the oil phase to solubility in aqueous phase

A. Osmotic gradient
B. Partition coefficient
C. Solubility gradient
D. Absorption coefficient
E. Diffusion coefficient

A

Partition coefficient

160
Q

The volume of blood that perfuses the liver which is cleared of drug per unit of time

A. Cardiac output
B. Regional blood flow
C. Hepatic clearance
D. Renal clearance
E. Body clearance

A

Hepatic clearance

161
Q

The total body clearance for a drug is 15 mL/min/kg. Renal clearance accounts for 10 mL/min/kg. What is the hepatic clearance for the drug?

A. 15 mL/min/kg
B. 10 mL/min/kg
C. 5 mL/min/kg
D. 3 mL/min/kg
E. 1 mL/min/kg

A

5 mL/min/kg

162
Q

Acetaminophen is converted to a reactive metabolite which causes hepatic necrosis thru what biotransformation reaction?

A. Demethylation
B. Acetylation
C. Aromatic hydroxylation
D. Deamination
E. Conjugation

A

Aromatic hydroxylation

163
Q

Codeine is converted to morphine thru what biotransformation reaction?

A. Demethylation
B. Acetylation
C. Aromatic hydroxylation
D. Deamination
E. Conjugation

A

A. Demethylation

164
Q

These drugs are inactive and must be biotransformed in the body to metabolites that have pharmacologic activity:

A. Enteric coated drugs
B. Prodrugs
C. Orphan drug
D. Xenobiotics
E. Lead drug

A

Prodrugs

165
Q

Which of the following is under phasa I biotransformation reaction?
I. Aormatic hydroxylation
II. Deamination
III. Nitroreduction
IV. Glycine conjugation
V. Methylation

A. I, II, III
B. I, II, IV
C. II, III, IV
D. III, V
E. IV, V

A

I, II, III

166
Q

Which of the following is under phase II biotransformation reaction?
I. Aormatic hydroxylation
II. Deamination
III. Nitroreduction
IV. Glycine conjugation
V. Methylation

A. I, II, III
B. I, II, IV
C. II, III, IV
D. III, V
E. IV, V

A

IV, V

167
Q

CYP450 enzyme responsible for metabolism of warfarin, phenytoin and losartan:

A. CYP2C9
B. CYP2D6
C. CYP2C19
D. CYP3A4
E. CYP1A2

A

CYP2C9

168
Q

Which of the following CYP450 enzyme is prone to genetic polymorphism?
I. CYP2C9
II. CYP2D6
III.CYP2C19
IV.CYP3A4

A. I only
B. I, II
C. II, III
D. I, II, III
E. IV only

A

I, II, III

169
Q

The most highly polymorphic CYP with more than 70 allelic variants reported

A. CYP2C9
B. CYP2D6
C. CYP2C19
D. CYP3A4
E. CYP1A2

A

CYP2D6

170
Q

The most abundant CYP450 in the liver and metabolizes over 50% of the clinically used drugs:

A. CYP2C9
B. CYP2D6
C. CYP2C19
D. CYP3A4
E. CYP1A2

A

CYP3A4

171
Q

Responsible for the metabolism of about 5% of marketed drugs including fluvoxamine, clozapine, olanzapine and theophylline:

A. CYP2C9
B. CYP2D6
C. CYP2C19
D. CYP3A4
E. CYP1A2

A

CYP1A2

172
Q

Polymorphisms of this phase 1 enzyme result in a loss of enzymatic activity leading to the accumulation of the chemotherapeutic agent 5-flourouracil, which leads to significant toxicity including leukopenia, thrombocytopenia, and stomatitis.

A. CYP450 transferase
B. Plasma pseudocholinesterase
C. Dihydropyrimidine
D. Glutathione
E. N-acetyl transferase

A

Dihydropyrimidine

173
Q

The metabolism of procainamide, hydralazine and isoniazid is dependent on this phase II enzyme:

A. Uridine Diphosphate
B. Thiopurine S-methyltransferase
C. Glutathione transferase
D. N-acetyltransferase
E. CYP450 enzyme

A

N-acetyltransferase

174
Q

An assay intended to determine interindividual variations in DNA sequence related to drug absorption and disposition (pharmacokinetics) or drug action (pharmacodynamics), including polymorphic variation in the genes that encode the functions of transporters, metabolizing enzymes, receptors, and other proteins:

A. Pharmacogenomic test
B. Genome determination
C. Polymorphic test
D. Pharmacogenetics
E. Pharmacogenetic

A

Pharmacogenetic

175
Q

An assay intended to study interindividual variations in the whole genome of candidate gene, single nucleotide polymorphism (SNP) maps, haplotype markers, or alterations in gene expression or inactivation that may be correlated with pharmacological function and therapeutic response. In some cases, the pattern or profile if change is the relevant biomarker, rather than changes in individual markers.

A. Pharmacogenomic test
B. Genome determination
C. Polymorphic test
D. Pharmacogenetics
E. Pharmacogenetic

A

Pharmacogenomic test

176
Q

Genome wide analysis of the genetic determinants of drug efficacy and toxicity:

A. Pharmacogenomic test
B. Pharmacogenomics
C. Polymorphism test
D. Pharmacogenetics
E. Pharmacogenetic test

A

Pharmacogenomics

177
Q

The systemic absorption of drug is dependent on the following factors, EXCEPT:

A. The physicochemical properties of drug
B. The nature of the drug product
C. The anatomy and physiology of the drug absorption site
D. Drug liberation from the dosage form
E. Distribution of drugs to target tissues/organ

A

Distribution of drugs to target tissues/organ

178
Q

Which of the following is not an advantage of parenteral route of administration?
I. Drug is given for immediate effect
II. Plasma drug level more precisely controlled
III. Decrease chance for adverse drug reaction
IV. Prevents tissue damage at the site of injection

A. I and II
B. II and III
C. III and IV
D. I and III
E. IV only

A

III and IV

179
Q

Which of the following is not an advantage of enteral route of administration?
I. No 1st pass effect for buccal or sublingual route
II. Safest and easiest route of administration
III. Rectal route is useful for patient who cannot swallow
IV. Complete drug absorption

A. I and II D. I and III
B. II and III E. IV only
C. III and IV
D. I and III
E. IV only

A

IV only

180
Q

This age group is the most medicated group of patients and receive the highest proportion of medications:

A. 15-24 yrs D. 45-65
B. 25-35 yrs E. >/= 65 yrs
C. 35-45 yrs
D. 45-65
E. >/= 65 yrs

A

> /= 65 yrs

181
Q

All of the following is/are drug absorption characteristics for older adults, EXCEPT:
I. Increased gastric pH
II. Delayed gastric emptying
III. Decreased absorption surface
IV. Increased gastrointestinal motility

A. I only
B. I and II
C. II and III
D. III and IV
E. IV only

A

IV only

182
Q

Which of the following is/are true regarding transdermal drug absorption?
I. Not advisable for older patients
II. There is significant difference in absorption of drugs between young and old individuals
III. Applicable for highly lipophilic chemicals
IV. Fentanyl is an example of drug administered thru transdermal route

A. I only
B. I and II
C. II and III
D. III and IV
E. IV only

A

III and IV

183
Q

Which of the following are/is true regarding subcutaneous drug absorption?
I. Drug absorption is through the vascular capillaries and lymphatic channels
II. Molecular size of the drug primarily determines the passage across the capillary endothelium
III. Subcutaneous absorption of drugs is not affected by aging
IV. Most common route of administration for therapeutic peptides a d proteins

A. I only
B. I, II and III
C. I, II and IV
D. II, III, and IV
E. IV only

A

I, II and IV

184
Q

All of the following are true regarding pulmonary drug absorption characteristic, EXCEPT:

A. Age is an important parameter that affects the pharmacokinetics of inhaled drugs
B. Lung anatomy and physiology change with age which can effect pulmonary drug absorption
C. Young adults show a decrease of the alveolar surface a variation of lung elasticity and a decrease of the alveolar capillary volume
D. There has been very little research for the pharmacokinetic and pharmacodynamics characteristics of new inhaled drugs in older patients
E. Decrements in cognition praxis and executive function that are highly prevalent in frail older individuals have a profoundly detrimental effect on inhaler technique

A

Young adults show a decrease of the alveolar surface a variation of lung elasticity and a decrease of the alveolar capillary volume

185
Q

Which of the following are the two major factors of aging on drug distribution?

A. Route of administration and GI motility
B. 1st pass metabolism and drug clearance
C. Tissue fluidpH and urine pH
D. Gastric emptying and intestinal metabolism
E. Plasma protein concentration and body composition

A

Plasma protein concentration and body composition

186
Q

Which of the following are the two major drug binding proteins in plasma?

A. Albumin and alpha1 acid glycoprotein
B. Nucleoprotein and albumin
C. Glycoprotein and lipoprotein
D. Enzymes and bile
E. Albumin and lipoprotein

A

Albumin and alpha1 acid glycoprotein

187
Q

Combination of clarithromycin and warfarin may result to:

A. Decreased warfarin exposure and decreased anticoagulant effect
B. Decreased clarithromycin exposure and decreased antibacterial effect
C. Risk increased warfarin exposure and increased anticoagulant effect
D. Increased clarithromycin exposure and increased antibacterial effect
E. Increased toxicity of clarithromycin and warfarin

A

Risk increased warfarin exposure and increased anticoagulant effect

188
Q

Which of the following is the most appropriate choice related to aging?

A. Increased extracellular fluid volume
B. Increased hepatic blood flow
C. Increased amount of sleep required
D. Increased subcutaneous fat as a percentage of total body mass
E. Increased size of alveolar ducts in the lung

A

Increased size of alveolar ducts in the lung

189
Q

Which of the following is the most appropriate choice to describe age associated changes that can affect pharmacokinetics in older patients?

A. Changes in gastrointestinal function that lead to reduced drug absorption
B. Increase in total body water
C. Decrease in body fat
D. Decrease in serum albumin concentrations with advancing age
E. Decrease in creatinine clearance with advancing age

A

Decrease in creatinine clearance with advancing age

190
Q

Which of the following statement regarding renal function and Pharmacokinetics in older patients is most accurate?

A. Decreased muscle mass is the reason for normal or low serum creatinine concentration in older patients even in the presence of decreased renal function
B. Renal tubular secretion is not changed with aging
C. Serum creatinine concentration of 1.5mg/dL reflects normal renal function in older men
D. Glomerular function always declines with aging
E. Gentamicin an be used safely in older patients with serum creatinine concentrations of 1.7mg/dL

A

Decreased muscle mass is the reason for normal or low serum creatinine concentration in older patients even in the presence of decreased renal function

191
Q

Which of the following statements concerning the safety of medications used by older patients is wrong?

A. Chlorpropamide can cause hypoglycemia
B. Benzodiazepines have large volume of distribution and are thus relatively safe for use in older people
C. Amantadine excretion depends on renal function and may cause confusion and falls if the dose is not adjusted for renal impairment
D. Diphenhydramine may exacerbate urinary retention of older men
E. Meperidine is not an effective oral analgesic in dosages commonly used and may cause neurotoxicity

A

Wala sagot

192
Q

BMI (kg/m2) of an obese patient

A. <18.5
B. 18.5 - 24.9
C. 25 - 29.9
D. 30 - 39.9

A

30 - 39.9

193
Q

BMI (kg/m2) of an individual with a normal body weight

A. <18.5
B. 18.5 - 24.9
C. 25 - 29.9
D. 30 - 39.9

A

18.5 - 24.9

194
Q

All of the following statements are true regarding obesity, EXCEPT

A. Defined as body mass index (BMI) of 30 or higher and already has recognized as a “disease”
B. Obesity related chronic conditions includes diabetes, hypertension, high cholesterol, stroke, heart disease certain cancers and arthritis
C. Obesity was associated with significantly increased mortality from cardiovascular diseases and obesity related cancers
D. Clinically a patient may be considered obese when the total body weight (TBW) is equal to or greater than 20% of ideal body weight (IBW)
E. Individuals with obesity also have significantly higher health related quality of life scores than those individuals with normal weights

A

Individuals with obesity also have significantly higher health related quality of life scores than those individuals with normal weights

195
Q

Which of the following factors listed below influence drug distribution in the body?
I. 1st pass metabolism
II. Tissue perfusion
III. Tissue membrane permeability
IV. Physicochemical property of drug

A. I, II and III
B. II, III and IV
C. I, II and IV
D. I, III and IV
E. I and IV

A

II, III and IV

196
Q

All of the following are drug distribution characteristic for obese patient EXCEPT:

A. The obese individuals have an increased total tissue mass and adipose tissue mass thereby increasing volume of distribution
B. Lipophilicity plays a major role in the drug distribution in obese individuals
C. In the obese patients, lipophilic medications show a high increased volume of distribution
D. The concentrations of plasma binding proteins, albumin, alpha 1 acid glycoprotein, and lipoprotein may be unchanged (albumin) increased or decreased (alpha 1 acid glycoprotein) with obesity
E. Hydrophilic medications showed a high increased in volume of distribution in obese individuals

A

Hydrophilic medications showed a high increased in volume of distribution in obese individuals

197
Q

Which of the following ais true regarding pharmacokinetic characteristics of obese individuals?
I. For phase 1 metabolism CYP 3A4 activity was consistently higher in the obese group
II. Renal clearance is increased in the obese patients due to increased glomerular filtration and tubular secretion
III. Enzyme activities of CYP 2E1 and xanthine oxidase were consistently higher in the obese group

A. I only
B. I and II
C. II and III
D. I and III
E. III only

A

II and III

198
Q

For nos. 198 - 199

Anjellie, a 45 year old female was admitted to the hospital with chief complaints of shortness of breath, wheezing, chills, and fever. Past medical history included hypertension arthritis and asthma. The patients weight and height were 300lb and 5’4 respectively:
Which of the following is correct for this patients body mass index (BMI)?

A. 35
B. 39.3
C. 60.9
D. 54.2
E. 51.6

A

35

199
Q

For nos. 198 - 199

If this patient has a serum creatinine of 1.0mg/dL calculate her estimated creatinine clearance in mL/min using adjusted body weight in the Cockcroft gault equation
A. 115.3
B. 98
C. 61.3
D. 152.9
E. 120

A

98

200
Q

Which of the following CYP450 isoenzymes showed a reduced activity in the obese patients?
A. CYP3A4
B. CYP2E1
C. CYP2C9
D. CYP2D6
E. Xanthine oxidase

A

CYP3A4

201
Q

Which of the following statements most accurately reflects the physiological changes commonly occurred with obesity?

A. Glomerular filtration is usually increased in the obese patients
B. Tubular reabsorption is usually increased in the obese patients
C. Tubular secretion is usually decreased in the obese patients
D. The activity of uridine diphosphate glucoronosyltranferase is usually decreased in the obese patients
E. The size of the kidney is usually smaller in the obese patients

A

Glomerular filtration is usually increased in the obese patients

202
Q

Which of the following statements most accurately reflects an appropriate drug dosing strategy for the obese patients?

A. The TBW should always be used to calculate the Loading dose for the obese patients
B. The IBW should always be used to calculate the loading dose for the obese patients
C. The TBW should always be used to calculate the maintenance dose for the obese patients
D. The IBW should always be used to calculate the maintenance dose for the obese patients
E. Applying the pharmacokinetic principles and using modified weight strategies combining with therapeutic drug monitoring

A

Applying the pharmacokinetic principles and using modified weight strategies combining with therapeutic drug monitoring

203
Q

Which of the following are range is classified as infant?

A. Born at gestational age <38 weeks
B. 0-4 weeks postnatal age
C. 1 month to 2 years of age (1 month to <12 months old)
D. 2-12 years of age (1-12 years old)
E. 12-21 years of age (13-16, 18 or 19 years old)

A

1 month to 2 years of age (1 month to <12 months old)

204
Q

Which of the following age range is classified as child?

A. Born at gestational age <38 weeks
B. 0-4 weeks postnatal age
C. 1 month to 2 years of age (1 month to <12 months old)
D. 2-12 years of age (1-12 years old)
E. 12-21 years of age (13-16, 18 or 19 years old)

A

2-12 years of age (1-12 years old)

205
Q

Calculation of child dose using Young’s rule is based on

A. Age
B. Weight
C. BSA
D. BMI
E. Dosage

A

Age

206
Q

Calculation of child dose using Clark’s rule is based on

A. Age
B. Weight
C. BSA
D. BMI
E. Dosage

A

Weight

207
Q

All of the following are drug absorption characteristic of pediatric patients EXCEPT

A. In neonates, the Gastric pH is >4 and gastric emptying and intestinal transit are faster
B. In infants, the pH is 2-4 with increasing emptying and transit time but biliary function is near the adult pattern
C. Low gastric pH in neonates and infants result in higher Bioavailability (F) of acid labile drugs such as penicillin G, ampicillin, and nafcillin
D. The fast GI transit reduces the rate and extent of absorption in neonates, infants and young children
E. The neonates are difficult to absorb fat soluble vitamins compared to infants and children due to the immature biliary function

A

Low gastric pH in neonates and infants result in higher Bioavailability (F) of acid labile drugs such as penicillin G, ampicillin, and nafcillin

208
Q

All of the following are drug distribution characteristic of pediatric patients EXCEPT

A. Changes in plasma protein concentration total body fat as well as total body water and extracellular water are the three major factors exerting significant effects on drug distribution in pediatric population
B. The total body water is low in pediatric patients resulting to increase volume of distribution of hydrophilic drugs
C. The protein concentration are low in the neonates and infants up to one year old resulting to a high concentration of unbound drug
D. In neonates and young infants phenytoin has a higher unbound fraction of the drug in circulation to exert activity
E. The age dependent Vd of lipophilic drugs is less apparent on pediatric population

A

The total body water is low in pediatric patients resulting to increase volume of distribution of hydrophilic drugs

209
Q

Defined as those drugs where comparatively small differences in dose or concentration lead to dose and concentration dependent, serious therapeutic failures and/or serious adverse drug reactions

A. Critical dose drugs
B. Narrow therapeutic index [NT] drugs
C. Prohibited and restricted drugs
D. A or B
E. A or C

A

A or B

210
Q

Which of the following are functions of therapeutic drug monitoring services?
I. Design dosage regimen
II. Perform pharmacokinetic evaluation of drug concentrations
III. Monitor serum drug concentrations
IV. Compounding of intravenously administered drugs

A. I and II
B. II and III
C. I, II and III
D. II, III and IV
E. I, II and IV

A

I, II and III

211
Q

The degree of reproducibility of the test results obtained by the analysis of the same samples by different analytical laboratories or by different instruments

A. Precision
B. Sensitivity
C. Accuracy
D. Ruggedness
E. Specificity

A

Ruggedness

212
Q

The minimum detectable level or concentration of drug in serum that maybe approximated as the lowest drug concentration that is two to three times the background noise:

A. Dynamic range
B. Sensitivity
C. Accuracy
D. Ruggedness
E. Linearity

A

Sensitivity

213
Q

Measurement of the variability or reproducibility of the data. Measurements are obtained by replication of various drug concentrations and by replication of standard concentration curves prepared separately on different days

A. Precision
B. Sensitivity
C. Accuracy
D. Ruggedness
E. Specificity

A

Precision

214
Q

Refers to the difference between the average assay values and the true or known drug concentrations

A. Precision
B. Sensitivity
C. Accuracy
D. Ruggedness
E. Specificity

A

Accuracy

215
Q

Pharmaceutical product that delivers a recombinant gene to somatic cells in vivo

A. Monoclonal antibody
B. Gene therapy
C. Antisense drugs
D. RNAi
E. Biopharmaceuticals

A

Gene therapy

216
Q

Drugs that seek to block DNA transcription or RNA translation in order to moderate many disease processes

A. Monoclonal antibody
B. Gene therapy
C. Antisense drugs
D. RNAi
E. Biopharmaceuticals

A

Antisense drugs

217
Q

Which of the following is not a requirement for effective oral drug delivery of protein and peptide drug?

A. Protection of the drug from degradation while in the harsh environment of the digestive tract
B. Consistent absorption of the drug in a manner that meets Bioavailability requirements
C. Consistent release of the drug so that it enters the bloodstream in a reproducible manner
D. Delivery of the drug through the GI tract or other organ and maintenance of pharmacologic effect similar to IV injection
E. None of these

A

None of these

218
Q

What is the most frequent route of administration of biologic compounds?

A. Parenteral
B. Oral
C. Buccal
D. Sublingual
E. Rectal

A

Wala sagot

219
Q

A dosage form that allows at lead a two fold reduction in dosage frequency as compared to that drug presented as an immediate release (conventional) dosage form:

A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

A

Extended release drug products

220
Q

Developed to disintegrate rapidly in the saliva after oral administration. The drug is dispersed in saliva and swallowed with little or no water.

A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

A

Orally disintegrating tablets

221
Q

Dosage form that releases drug at or near the intended physiologic site of action:

A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

A

Targeted release drug products

222
Q

Designed to release a drug at a predetermined rate for the constant drug concentration maintaining during a specific period of time. The drug may release its medication properties over a controlled mode within a certain period where the drug is released bit by bit in the body.

A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

A

Orally disintegrating tablets

223
Q

Drug product designed to produce an instant effect where once administered the effects took place immediately and its extended effect would be often happened at an hourly basis. When the drug concentration goes down, this drug product may have the capability to maintain the effectiveness by the formulation itself

A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

A

Enteric coated tablets

224
Q

Type of modified release drug product that is designed to release one dose of drug initially followed by a second or more doses of drug at a later time

A. Extended release drug products
B. Delayed release drug products
C. Targeted release drug products
D. Orally disintegrating tablets
E. Enteric coated tablets

A

Delayed release drug products

225
Q

All of the following are advantage of extended release drug product EXCEPT
I. Sustained therapeutic blood levels of the drug
II. Improved patient compliance
III. Reduction in adverse side effects and improvement in tolerability
IV. Dose dumping
V. Less possibility for high dose

A. I and II
B. II nad III
C. III and IV
D. IV and V
E. I and V

A

Wala sagot

226
Q

Defined either as the release of more than the intended fraction of drug or as the release of drug at a greater rate than the customary amount of drug per dosage interval such that potentially adverse plasma levels may be reached

A. Drug accumulation
B. Dose dumping
C. Prolonged drug release
D. Over-extended release
E. A or B

A

Dose dumping

227
Q

Extended release tablets foe treatment of angina and hypertension

A. Acutrim
B. Minipress XL
C. Procardia XL
D. Adalat CR
E. Volmax

A

Procardia XL

228
Q

Extended release tablets for the relief of bronchospasm in patients with reversible obstructive airway disease

A. DynaCirc CR
B. Minipress XL
C. Procardia XL
D. Adalat CR
E. Volmax

A

Volmax

229
Q

Extended release tablets indicated as an adjunct to diet for the control of hyperglycemia in patients with non insulin dependent diabetes

A. Glucotrol XL
B. Covera HS
C. Procardia XL
D. Adalat CR
E. Efidac 24

A

Glucotrol XL

230
Q

Systemic, scientific, risk based, holistic, and proactive approach to pharmaceutical development that begins with predefined objectives and emphasizes the understanding of product and processes and process control

A. Quality by design (QbD)
B. Process analytical technology (PAT)
C. Process development
D. Design space
E. Risk based regulation

A

Quality by design (QbD)

231
Q

The geometrical region suitable for quality manufacturing when two/more process/material variables are plotted in a two dimensional or higher dimensional space to show the combined effects of the relevant processing variables during manufacturing.

A. Quality by design (QbD)
B. Process analytical technology (PAT)
C. Process development
D. Design space
E. BioRAM

A

Design space

232
Q

Optimizes drug product development and performance by using therapy driven target drug delivery profiles as a framework to achieve the desired therapeutic outcome.

A. Quality by design (QbD)
B. Process analytical technology (PAT)
C. Process development
D. Design space
E. BioRAM

A

BioRAM

233
Q

A system for designing, analysing and controlling manufacturing through timely measurements (ie,during processing) of critical quality and performance attributes of raw and in process materials and processes with the goal of ensuring final product quality.

A. Quality by design (QbD)
B. Process analytical technology (PAT)
C. Process development
D. Design space
E. Risk based regulation

A

Process analytical technology (PAT)

234
Q

Therapeutic equivalence of a generic drug product with an innovator drug is assumed when the following conditions are met.
I. They are approved as safe and effective
II. They are pharmaceutical equivalents and bioequivalents
III. They are adequately labelled
IV. They are manufactured in compliance with current good manufacturing practice regulations
V. They have the same time

A. I, II and III
B. II, III nad IV
C. III, IV and V
D. I, II, III and IV
E. I, II, III, IV and V

A

I, II, III and IV

235
Q

Pharmaceutical equivalent products may differ in which of the following aspects?
I. Active ingredients
II. Excipients
III. Impurities
IV. Release mechanism
V. Dosage form

A. I, II and III
B. II, III and IV
C. III, IV and V
D. I, II and V
E. II, IV and V

A

II, III and IV

236
Q

The most common way to estimate the ability of the liver to metabolize drug is to determine the Child-Pugh score for a patient. All of the following are laboratory tests / clinical symptoms included in this test EXCEPT

A. Serum albumin
B. Total albumin
C. Prothrombin time
D kidney encephalopathy
E . Ascites

A

kidney encephalopathy

237
Q

Which of the following is not true for patients with heart failure?

A. There is a decline of hepatic clearance for drugs with moderate - high hepatic extraction ratio
B. Increase Bioavailability of drugs
C. The volume of distribution for some drugs decreases in patients with heat failure
D. There is change in drug pharmacokinetic due to change in renal blood flow
E. Half-life of drug is difficult to predict in patients with renal failure

A

Increase Bioavailability of drugs

238
Q

The fluid portion of a sample of whole blood allowed to clot for 30 minutes before centrifugation is

A. Serum
B. Plasma
C. Serous fluid
D. Citrate blood
E. Platelet

A

Serum

239
Q

The fluid portion of whole blood centrifuged before clot formation is called

A. Serum
B. Plasma
C. Serous fluid
D. Citrate blood
E. Platelet

A

Plasma

240
Q

Which of the following drugs listed below has the least percentage of protein binding?

A. Ampicillin
B. Chloramphenicol
C. Lidocaine
D. Phenytoin
E. Vancomycin

A

Ampicillin

241
Q

Which of the following drugs listed below has the highest percentage of protein binding?

A. Ampicillin
B. Chloramphenicol
C. Lidocaine
D. Phenytoin
E. Vancomycin

A

Phenytoin

242
Q

Which of the following statements best describes F?

A. Rate of absorption of the administered drug into the systemic circulation
B. Amount of administered drug that reaches the systemic circulation
C. Speed at which the administered drug reaches the systemic circulation
D. Fraction of the administered drug that reaches the systemic circulation
E. Amount of drug absorbed after drug dissolution

A

Fraction of the administered drug that reaches the systemic circulation

243
Q

If 500mg of a drug is given orally and 250mg is absorbed into the systemic circulation, What is F?

A. 0.2
B. 0.3
C. 0.4
D. 0.5
E. 0.6

A

0.5

244
Q

Antifungal drug used to treat systemic mycoses which is available in a liposomal formulation that is less nephrotoxic and better tolerated than the conventional form

A. Heparin
B. Levodopa
C. Amphotericin
D. Nystatin
E. Griseofulvin

A

Amphotericin

245
Q

Which of the following drug is present in the extracellular fluid compartment of the body?

A. Phenytoin
B. Ethanol
C. Morphine
D. Gentamicin
E. Haloperidol

A

Haloperidol

246
Q

Which of the following drugs listed below Is a substrate of CYP2D6 isoenzyme?

A. Caffeine
B. Paclitaxel
C. Phenytoin
D. Alcohol
E. Codeine

A

Codeine

247
Q

Which of the following is not a prodrug?

A. Azathioprine
B. Prednisone
C. Zidovudine
D. Morphine
E. Enalapril

A

Morphine

248
Q

All of the following are true regarding drug elimination by the kidney EXCEPT

A. Most of drugs unless highly bound to plasma protein cross the glomerular filter freely
B. Many drugs especially weak acids and weak bases are reactively secreted into the renal tubule and thus more rapidly excreted
C. Water soluble drugs are passively reabsorbed by diffusion across the tubule so are not efficiently excreted in the urine
D. Because of pH partition weak acids are more rapidly excreted in alkaline urine and vice versa
E. Several important drugs are removed predominantly by renal excretion and are liable to cause toxicity in elderly persons and patients with renal disease

A

Water soluble drugs are passively reabsorbed by diffusion across the tubule so are not efficiently excreted in the urine

249
Q

A requirement imposed by FDA for in vitro and/or in vivo testing of specified drug products which must be satisfied as a condition of marketing

A. Bioavailability requirement
B. Bioequivalece requirement
C. Biowaiver
D. Regulatory requirement
E. Bioassay

A

Bioequivalece requirement

250
Q

Drug products that contain the identical therapeutic moiety or its precursor but not necessarily in the same amount or dosage form or as the same salt or ester

A. Pharmaceutical equivalents
B. Bioequivalents
C. Pharmaceutical alternative
D. Therapeutic equivalence
E. Therapeutic alternative

A

Pharmaceutical alternative

251
Q

Multisource drug product that has been approved by the FDA as a therapeutic equivalent to the reference listed drig product (usually the brand or innovator drug product) and has proven equivalent drug product performance

A. Innovator drug product
B. Orphan drug
C. Experimental drug
D. Generic drug product
E. Pharmaceutical equivalent product

A

Generic drug product

252
Q

Defined as the rate and extent to which the active ingredient or active moietyis absorbed from a drug product and becomes available at the site of action

A. Bioavailability
B. Bioequivalece
C. Drug absorption
D. Biowaiver
E. Drug liberation

A

Bioavailability

253
Q

Defined as the absence of a significant difference in the rate and extent to which the active ingredient or active moiety becomes available at the site of drug action when administered at the same molar dose under similar conditions in an appropriately designed study

A. Bioavailability
B. Bioequivalece
C. Relative Bioavailability
D. Biowaiver
E. Absolute Bioavailability

A

Bioequivalece

254
Q

Compares the Bioavailability of the active drug in the systemic circulation following extra vascular administration with the Bioavailability of the same drug following intravenous administration

A. Bioavailability
B. Bioequivalece
C. Relative Bioavailability
D. Biowaiver
E. Absolute Bioavailability

A

Absolute Bioavailability

255
Q

The systemic exposure of a drug in a designed formulation (generally reffered to as treatment A or reference formulation) is compared with that of the same drug administered in a reference formulation (generally reffered to as treatment B or reference formulation)

A. Bioavailability
B. Bioequivalece
C. Relative Bioavailability
D. Biowaiver
E. Absolute Bioavailability

A

Relative Bioavailability

256
Q

The Bioavailability of a new investigational drug was studied in 12 volunteers. Each volunteer received either a single oral tablet containing 200 mg of the drug 5mL of a pure aqueous solution containing 200 mg of the drug or a single IV bolus injection containing 50 mg of the drug. Plasma samples were obtained periodically up to 48 hours after the dose and assayed for drug concentration. The average AUC values (0-48 hours) are given 8n the table below.
From these data calculate the relative Bioavailability of the drug from the tablet compared to the oral solution

A. 100%
B. 101%
C. 102%
D. 103%
E. 104%

A

104%

257
Q

The absolute drug Bioavailability from the tablet is calculated:

A. 35.9%
B. 45.5%
C. 59.2%
D. 61.9%
E. 70.1%

A

59.2%

258
Q

Which of the following is not a drug absorption rate limiting step for solid oral immediate release drug products?

A. Disintegration of the drug product
B. Subsequent release of the drug
C. Dissolution of the drug in an aqueous environment
D. Absorption across cell membranes into the systemic circulation
E. Drug protein binding

A

Drug protein binding

259
Q

Which of the following is the slowest step and therefore exerts a rate limiting effect on drugs that have a very poor aqueous solubility?

A. Disintegration of the drug product
B. Subsequent release of the drug
C. Dissolution of the drug in an aqueous environment
D. Absorption across cell membranes into the systemic circulation
E. Drug protein binding

A

Dissolution of the drug in an aqueous environment

260
Q

For orally administered drug that has a high aqueous solubility which is the rate limiting step for drug absorption?

A. Disintegration of the drug product
B. Subsequent release of the drug
C. Dissolution of the drug in an aqueous environment
D. Absorption across cell membranes into the systemic circulation
E. Drug protein binding

A

Absorption across cell membranes into the systemic circulation

261
Q

Solid drug products exempted from disintegration tests includes which of the following?
I. Troches
II. Tablets that are intended to be chewed
III. Drug products intended for sustained release
IV. Sugar coated tablet

A. I and II
B. II and III
C. III and IV
D. I, II, and III
E. II, III and IV

A

I, II, and III

262
Q

Defined by the USP NF (National Formulary) as “that state in which any residues of the tablet except fragments of insoluble coating, remaining on the screen of the test apparatus in the soft mass have no palpably firm core”

A. Complete dissolution
B. Complete absorption
C. Complete drug liberation
D. Complete disintegration
E. A or B

A

Complete disintegration

263
Q

The process by which a solid drug substance becomes dissolved in a solvent over time:

A. Dissolution
B. Disintegration
C. Absorption
D. Liberation
E. Solubilization

A

Dissolution

264
Q

The Physicochemical property gives some indication of the relative affinity of the drug for oil and water. A drug that has high affinity for oil may have poor release and dissolution from the drug product

A. Hygroscopicity
B. Polymorphism
C. pKa and pH
D. Particle size
E. Partition coefficient

A

Partition coefficient

265
Q

Which of the following is true regarding solubility pH profile of a drug?
I. An acidic drug is more soluble in an acidic medium forming a soluble salt
II. A basic drug is more solublein the intestine forming a soluble salt
III. The solubility pH profilegives a rough estimation of the completeness of dissolution for a dose of a drug in the stomach or in the small intestine

A. I only
B. I and II
C. II and III
D. I and III
E. III only

A

III only

266
Q

Which of the following is trie regarding particle size and drug absorption
I. Dissolution rate is proportional to the surface area of the drug
II. The effective surface area of a drug is decreased enomously by a reduction in the particle size
III. Reduction of particle size increases the absorption of the drug

A. I only
B. I and II
C. II and III
D. I and III
E. III only

A

I and III

267
Q

Which of the following drug Excipients increases the absorption rate constant of a drug?

A. Lubricants
B. Disintegrants
C. Enteric coating
D. Sustained release agents
E. Coating agent

A

Disintegrants

268
Q

USP NF dissolution apparatus for extended release drug products

A. Apparatus 1
B. Apparatus 2
C. Apparatus 3
D. Apparatus 4
E. Apparatus 5

A

Apparatus 3

269
Q

USP NF dissolution apparatus for drug products containing low water soluble drugs

A. Rotating basket
B. Paddle
C. Reciprocating cylinder
D. Flow cell
E. Paddle over disk

A

Flow cell

270
Q

Which of the following dissolution apparatus is/are used for transdermal drug products?
I. Paddle over disk
II. Cylinder
III. Diffusion cell
IV. Reciprocating
V. Reciprocating disk

A. I and II
B. II and III
C. I, II and III
D. II, III, and IV
E. V only

A

I, II and III

271
Q

Static diffusion system that issued for characterizing drug permeation through a skin model. They are commonly available to characterize in vitro drug release and drug permeation kinetics from topically applied dosage form (eg. Ointment, Cream) or transdermal drug product

A. Paddle over disk
B. Reciprocating disk
C. Intrinsic dissolution method
D. Rotating bottle method
E. Franz diffusion cell

A

Franz diffusion cell

272
Q

A scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability

A. Biopharmaceutics classification system (BCS)
B. Pharmacokinetics classification system (PCS)
C. Absorption classification system (ACS)
D. Permeation classification system (PCS)
E. Solubility classification system (SCS)

A

Biopharmaceutics classification system (BCS)

273
Q

Biopharmaceutics classification system (BCS) class for drug substances with high solubility and low permeability

A. Class 1
B. Class 2
C. Class 3
D. Class 4
E. Class 5

A

Class 3

274
Q

Biopharmaceutics classification system (BCS) class for drug substances with low solubility and low permeability

A. Class 1
B. Class 2
C. Class 3
D. Class 4
E. Class 5

A

Class 4

275
Q

All of the following are true regarding colonic drug delivery EXCEPT

A. Drugs that are destroyed following oral administration by the acidic environment of the stomach or metabolized by enzymes may only be slightly affected in the colon
B. Crohn’s disease may be more effectively treated by direct drug delivery to the colon
C. Drig delivery to the colon is highly influenced by several factors including high bacterial level
D. Drugs such as metoprolol, NSAIDs, steroids, peptides, and vaccines are well absorbed in the colon
E. Not recommended for the delivery of proteins and therapeutic peptides

A

Not recommended for the delivery of proteins and therapeutic peptides

276
Q

Which of the following is true for rectal route of administration?

A. Many drugs are poorly or erratically absorbed across the rectal mucosa
B. Release of drug from a suppository does not depend on the composition of the suppository base
C. Not applicable for systemic delivery
D. Slow absorption of low molecular weight drugs
E. Prone to 1st pass metabolism

A

Many drugs are poorly or erratically absorbed across the rectal mucosa

277
Q

This component of a transdermal patch is important for maintaining uninterrupted skin contact for drug diffusion through the skin

A. Backing or support layer
B. Drug layer
C. Release controlling layer
D. Pressure sensitive adhesive
E. Protective strip

A

Pressure sensitive adhesive

278
Q

Ethyl vinyl copolymer is a component of which of the following part of transdermal patch?

A. Backing or support layer
B. Drug layer
C. Release controlling layer
D. Pressure sensitive adhesive
E. Protective strip

A

Release controlling layer

279
Q

These Excipients are incorporated into the drug product to promote system drug absorption fron the application site.

A. Absorption enhancers
B. Permeation enhancers
C. Systemic enhancers
D. A or B
E. A or C

A

A or B

280
Q

Part of the skin that is the major barrier to systemic drug absorption of transdermal products

A. Stratum granulosum
B. Stratum corneum
C. Stratum lucidum
D. Stratum spinosum
E. Stratum basale

A

Stratum corneum

281
Q

Estraderm(brand name) , and estradiol transdermal contains ethanol which serves as which of the following?

A. Provide soothing effect to the skin
B. Promotes drug delivery to stratum corneum
C. Increases stability of the patch
D. Prevents microbial growth on the patch
E. Potentiate the effect of the patch

A

Promotes drug delivery to stratum corneum

282
Q

A technique using a small electric charge to deliver drug containing an ionic charge through the stratum corneum

A. Charge induction
B. Ionic charge delivery
C. Sonophoresis
D. Electrophoresis
E. Iontophoresis

A

Iontophoresis

283
Q

This parenteral route of administration is often used for allergy and other diagnostic tests such as tuberculosis

A. Intradermal injection
B. Intra-arterial injection
C. Intrathecal injection
D. Subcutaneous injection
E. Intravenous infusion

A

Intradermal injection

284
Q

Parenteral route of administration generally used for insulin injection

A. Subcutaneous injection
B. Intravenous injection
C. Intramuscular injection
D. Intravenous infusion
E. Intradermal injection

A

Subcutaneous injection

285
Q

Which of the following is the safest and easiest route of drug administration?

A. Intravenous
B. Rectal (PR)
C. Oral (PO)
D. Inhalational
E. Intranasal

A

Oral (PO)

286
Q

In drug absorption some polar molecules may not be able to traverse the cell membrane but instead go through gaps or tight junctions between cells this process is known as

A. Transcellular absorption
B. Lipid diffusion
C. Facilitated diffusion
D. Paracellular drug diffusion
E. Active transport

A

Paracellular drug diffusion

287
Q

Cell membrane structure theory that states that the plasma membrane is composed of two layers of phospholipid between two surface layers of proteins with the hydrophilic “head” grouos of the phospholipids facing the protein layers and the hydrophobic “tail” groups of the phospholipids aligned in the interior.

A. Unit membrane theory
B. Fluid mosaic theory
C. Drug absorption theory
D. Hydrophilic - lipophilic balance theory
E. Phospholipid theory

A

Unit membrane theory

288
Q

According to this, the cell membrane consists of globular proteins embedded in a dynamic fluid, lipid bilayer matrix. These proteins provide a pathway for the selective transfer of certain polar molecules and charged ions through the lipid barrier.

A. Unit membrane theory
B. Fluid mosaic theory
C. Drug absorption theory
D. Hydrophilic - lipophilic balance theory
E. Phospholipid theory

A

Fluid mosaic theory

289
Q

According to the pH partition hypothesis if the pH on one side of the cell membrane differs from the pH on the other side of the membrane then:

A. The drug (weak acid or base) will ionize to different degrees on respective sides of the membranes
B. The total drug concentrations (ionized plus non ionized drug) on either side of the membrane will be equal
C. Compartment in which the drug is more highly ionized will contain the greater total drug concentration
D. A and B
E. A and C

A

A and C

290
Q

A carrier mediated transport system differing from the active transport in the drug mibes along the concentration gradient

A. Endocytosis
B. Passive diffusion
C. Pinocytosis
D. Facilitated diffusion
E. Connective transport

A

Facilitated diffusion

291
Q

Defined as a series of structurally related chemical compounds that have shown interesting pharmacological activity and from which drug candidates may be selected

A. Leads
B. Drug candidates
C. Drug substances
D. Active pharmaceutical ingredient
E. Drug product

A

Leads

292
Q

Defined as pharmacologically active compounds undergoing evaluation of their potential as future drug substances

A. Leads
B. Drug candidates
C. Drug substances
D. Active pharmaceutical ingredient
E. Drug product

A

Drug candidates

293
Q

The most important class of hydrolysis reactions influencing the stability of pro-drug and drug candidates

A. Hydrolysis of esters
B. Hydrolysis of amides
C. Hydrolysis of carboxyl functional group
D. Hydrolysis of alcohols
E. Hydrolysis of imides

A

Hydrolysis of carboxyl functional group

294
Q

Which of the following hydrolysable carboxyl compound is present on acetyl salicylic acid (ASA)?

A. Imide
B. Amide
C. Alcohol
D. Ester
E. Lactam

A

Ester

295
Q

Lipinski’s rule of five is based on an analysis of key Physicochemical properties of drug substances in the world drug index. The rule is based on four Physicochemical parameters that are globally associated with solubility and permeability and it states that the drug substances are most likely to have good Bioavailability when the following four parameters listed below are fullfilled EXCEPT

A. Number of hydrogen bond (H-bond)
B. Number of H bond acceptors <10
C. Molecular weight (MW) is <500
D. Logarithm of the calculated octano/water partition coefficient logP <5
E. Number of functional groups present <5

A

Number of functional groups present <5

296
Q

Carriers that have two or more substrates moving in one direction during the transport process are called

A. Antiports
B. Symports
C. Active transporters
D. Enzyme
E. Bioports

A

Symports

297
Q

Cell culture which serves as an easy screen of drug permeation and for prediction of human intestinal permeability and fraction of the oral dose absorbed in man

A. Caco-2 cells
B MDCK cell line
C. HepG2
D. MDCK-MDR1
E. HT-29

A

Caco-2 cells

298
Q

Which of the following is the pH of the stomach at fasting state?

A. 2.1 - 3.4
B. 4.2 - 5.1
C. 1.1 - 2.0
D. 4.1 - 5.2
E. 1.5 - 2.9

A

1.5 - 2.9

299
Q

The most common dissolution theory. This theory assumes that the dissolution rate is transport rate controlled and in fact most dissolution processes are controlled by this diffusion - convection - controlled step

A. Reaction rate theory
B. Film theory
C. Noyes whitney
D. Ficks theory
E. Transport rate theory

A

Film theory

300
Q

Cell lines used hepatic drug uptake and metabolism that have also been developed to serve as a tool for biotransformation studies in conjunction with drug transport

A. Caco-2 cells
B MDCK cell line
C. HepG2
D. MDCK-MDR1
E. HT-29

A

HepG2