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[FINALS] LU4 2018 > Ther 201 Exam 1 > Flashcards

Ther 201 Exam 1 Flashcards

1
Q
  1. Which does not fall under the scope of pharmacology?
    A. use of chemicals in prevention, diagnosis, and cure, especially for humans
    B. The undesirable effect of chemicals on living systems
    C. Use of genetic information for therapeutics
    D. Study of living systems and their physiology
A

Answer: D

A defines drugs, B pertains to toxicology, C is pharmacogenetics

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2
Q
  1. Which of the following contributed to modern day pharmacology?
    A. Development of experimental physiology and pharmacology
    B. Discovery of the biologic substrate of drug action
    C. Introduction of controlled clinical trials
    D. AOTA
A

Answer: D

All are important in the discovery and development of drugs

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3
Q
  1. Which of the following illustrates a pharmacokinetic property of furosemide?
    A. It causes diuresis
    B. It inhibits the Na/K/2Cl co-transporter in the thick ascending loop of Henle
    C. Its duration of action is 2-3 hours
    D. Furosemide has direct vascular effects
A

Answer: C
Pharmacokinetics pertains to the properties of drugs in terms of absorption, distribution, metabolism and elimination. Duration of action falls under elimination. A and B pertains to pharmacodynamics, the drug’s mechanism of action.

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4
Q
  1. Clinical Pharmacology training includes learning the following EXCEPT
    A. Prescribing effectively
    B. Application of therapeutic agents
    C. Preparing medicinal drugs
    D. Beneficial effects of drugs in individuals and society
A

Answer: C
Clinical pharmacology is the scientific discipline that involves all aspects of the relationship between drugs and human (intro trans). A, B and C involves ensuring benefit of the people when taking drugs.

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5
Q
  1. Which of the following issues in drug therapy is a major challenge to public health?
    A. Making sure that drugs are available
    B. Use of evidence-based medicine
    C. Adverse drug reactions
A

C

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6
Q
  1. True about drug-receptor interactions
    A. With the ligand, the receptor is always active
    B. Without the ligand, the receptor is always inactive
    C. The receptor only produces its effect when activated by the agonist
    D. Constitutive action is by unbound receptor in active conformation
A

C

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7
Q
  1. The binding of acetylcholine to its nicotinic receptor leads to
    A. Hyperpolarization
    B. Exit of Cl- ions
    C. Failure of generation of action potential
    D. Depolarization
A

Answer: D

Binding of acetylcholine leads to opening of the ligand-gated ion channel, sodium enters leading to cell depolarization

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8
Q 
9. Which of the following receptors is expected to have the quickest biologic response after the ligand has bound to the binding site?
A. Ion channel
B. GPCR
C. Cytoplasmic/intracellular receptor
D. Enzyme-linked
A

Answer: A
Opening of ion channels causes immediate change in ion gradient leading to depolarization. B,C,D needs more time, since it has to activate secondary messengers

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9
Q 
12. Glucagon acts through what receptor?
A. Ionophore
B. G-protein coupled
C. Tyrosine kinase
D. Cytoplasmic/intracellular
A

C

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10
Q 
13. Anesthetics like tubocurarine induce skeletal muscle relaxation by:
A. Induce entry of Na+
B. Inhibit entry of Na+
C. Induce exit of Na+
D. Inhibit exit of Na+
A

Answer: B
Tubocurarine competes with acetylcholine at the nicotinic receptor (competitive inhibition), thus inhibiting the entry of Na+ through the channel

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11
Q 
14. Allosteric activators produce an action that may be described as:
A. Greater than agonist alone
B. Equal to agonist
C. Less than agonist alone
D. Opposite to agonist
A

Answer: A
Allosteric activators act on a binding site different from the receptor. This alters the receptor function that may produce a greater effect than just giving the agonist.

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12
Q
  1. Tamoxifen is a partial estrogen agonist. As a partial agonist, it
    A. Produces the same effects as estrogen on all tissues in high doses
    B. Antagonizes estrogen in breast tissue and agonizes estrogen effect on bones
    C. Agonizes estrogen effects but antagonizes estrogen effects at higher levels/doses
    D. Induces conformational change in estrogen to inactivate it
A

Answer: B
Tamoxifen is a selective estrogen receptor modulator (SERM) used as an anti-neoplastic agent in breast cancer (estrogen antagonist in breast), but it may prevent loss in bone density (estrogen agonist in bone)
Partial agonists produce a lower response than a full agonist.

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13
Q 
16. The mode of action of this drug is mediated by G-protein coupled receptor
A. The hormone insulin
B. The glucocorticoid prednisone
C. Salbutamol
D. Diazepam
A

Answer: C
Salbutamol is a beta receptor agonist, activated by the cAMP pathway. Insulin acts via the tyrosine kinase receptors, prednisone through nuclear receptor and Diazepam through the ligand gated chloride channel

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14
Q 
17. Which of the following drugs has a non-receptor mediated mechanism of action?
A. Epinephrine
B. Mannitol
C. Ipatropium (anti-adrenergic)
D. Carbamezapine
A

Answer: B
Mannitol is an osmotic diuretic, acting by causing an osmotic gradient to increase urine output. Epinephrine acts at the alpha and beta receptors, ipratropium is an anticholinergic agent (antagonist at muscarinic receptor), and Carbamazepine is acts at sodium channels in the neurons (stabilize inactive state)

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15
Q
  1. Which of the following is the expected outcome when receptors are continuously and chronically exposed to agonists?
    A. Up-regulation of receptors
    B. Formation of B-arrestin
    C. Down-regulation of receptors
    D. Increased sensitivity to agonist action leading to greater biologic effect
A

Answer: C
Continuous exposure to agonist may cause tachyphylaxis with an end outcome of receptor down regulation to dampen response to the agonist.

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16
Q
  1. The binding of diazepam to its receptor causes the following events
    A. Separation of Gs alpha protein from G-beta and G-gamma protein subunits
    B. Autophosphorylation of the beta-subunit of the receptor
    C. Direct opening of the ionophore channel causing exit of sodium
    D. Conformotional change of GABA receptor causing improved GABA binding and action
A

Answer: D

Mechanism of action of diazepam

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17
Q
  1. The binding of a ligand or drug on the cytoplasmic/nuclear receptor lead to biologic effects that are
    A. Expected within seconds to minutes
    B. Terminated once drug concentration becomes low or zero
    C. Delayed but once these manifest, are also short-lived
    D. Persistent for hours or days even when the drug has been eliminated from the body
A

Answer: D
Drugs acting on nuclear receptors have delayed activity since DNA transcription is necessary before action can be elicited, but the activity persists since the effect in DNA transcription continues even after the drug is eliminated

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18
Q 
21. What type of receptor is used by EGF and other growth factors?
A. Enzyme linked
B. G-coupled protein
C. Ligand-gated ion channel
D. Intracellular/nuclear receptor
A

Answer: A

Specifically through tyrosine kinase receptors (PDGF, EGF, VEGF)

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19
Q 
22. The effector molecules of a G-coupled receptor like the muscarinic receptor is
A. Adenylyl cyclase
B. Phospholipase C
C. Tyrosine kinase
D. Chloride channel
A

Answer: A

Activation of muscarinic receptor leads to the activation of Phospholipase C

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20
Q 
23. A newly discovered VEGF inhibitor for cancer has just finished FDA approval November 2010 and was released to doctors and patients early 2011. Dr. Bueno, a medical oncologist, wanted to show the efficacy of the new drug to her patients with metastatic ovarian cancer Roche, a pharmaceutical company gave her a grant to gather all adverse events of the said drug
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
A

Answer: D
Phase 4 of Clinical trials is post-marketing surveillance where adverse events are monitored after the drug is released to the market

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21
Q 
25. Scientists want to discover the effects of the Zea mays plant on insulin resistance. A clinical trial conducted using rat models monitored the concentration of the plant in the kidneys using clot analysis and real time PCR. They also measured the blood sugar, serum insulin, and HBA1C
A. Phase 1
B. Phase 2
C. Pre-clinical
D. Phase 4
A

Answer: C

Pre-Clinical testing pertains to laboratory and animal testing done to determine drug safety and efficacy

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22
Q 
26. A new drug just got FDA approval. The test design included administration of 25 mg to 25 healthy patients. Results show T1/2 of \_\_\_ and Cmax of \_\_\_\_.
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
A

Answer: A
Phase 1 is testing the drug to 20-100 healthy volunteers, geared towards determining the safe dosing range and pharmacokinetic properties of the drug.

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23
Q
  1. ______-inferiority, open-labeled, randomized control trial involving ultra-long acting basal insulin was recently published in the Lancet. The study was conducted in 69 sites worldwide, involving Type 1 DM patients, and compared degludec with the long acting insulin Lantus. Results showed that there was a fall of 0.4% in the HbA1c using degludec. The manufacturer has already submitted the dossier to the FDA but has not been approved for marketing.
    A. Phase 4
    B. Phase 2
    C. Phase 3a
A

Answer: C

Phase 3a consists of randomized multi-center drug trials done before new drug application to determine drug efficacy

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24
Q 
28. The efficacy and safety of the ophthalmic solution Diquafasol was conducted in patients with Dry Eye Syndrome. The pilot study is a randomized, double-blind, multicenter, parallel-group, placebo controlled trial involving 286 Japanese patients who were randomized to either the drug group or placebo group. Results showed that 1% and 3% diquafasol is effective and safe.
A. Phase 1
B. Phase 2a
C. Phase 2b
D. Phase 2c or 3 (?)
A

Answer: B
Phase 2a studies evaluate the drug’s safety and efficacy in selected populations of patients with the disease to be treated, diagnosed or prevented. Objectives may focus on dose-response, type of patient, frequency of dosing or other safety and efficacy characteristics.
Phase 2b studies evaluate the drug’s safety and efficacy in patients with the disease to be treated, diagnosed or prevented. These studies represent the most rigrous demonstration of the drug’s efficacy, refered to as pivotal trials

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25
Q 
29. Dr. Ramos and his group of scientists wanted to study the newly discovered molecule GA101 on cancer patients. They used rat models showing the pharmacodynamics and pharmacokinetics of the molecule and were able to prove that it was able to decrease the size of the mass.
A. Pre-clinical
B. Phase 1
C. Phase 2
D. Phase 3
A

A

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26
Q 
30. Comparative study on effects of carvedilol vs metoprolol, randomized, 100 participants with DM2
A. Phase 1
B. Phase 2
C. Phase 3
D. Phase 4
A

Answer: B

Phase 2 trials evaluate the drug’s effectiveness in 1100-500 patients with the disease.

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27
Q
  1. Receptors have these characteristics except
    A. Are responsible for the selectivity of drug action
    B. Can create new functions by its binding to ligands
    C. Can mediate the actions of the pharmacologic agonists and antagonists
    D. Are generally macromolecular molecules which possess stereospecificity
    E. Can largely determine the quantitative relationship between drug dose or concentration and pharmacologic effects
A

Answer: B
New function is not produced with receptor-ligand binding.
Mechanisms of drug action trans: Receptors determine the quantitative relationship between dose and effects, responsible for selectivity of drug action and mediates the action of pharmacologic agonists and antagonists

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28
Q
  1. Drug-receptor interactions are subject to the following
    A. Downregulation such as desensitization
    B. Upregulation such as hyperactivity
    C. No regulation
    D. A and B only
    E. AOTA
A

D

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29
Q 
33. The 3 most important characteristics of a drug
A. Potency, safety, equality
B. Efficacy, safety, quality
C. Efficacy, safety, affordability
D. Potency, efficacy, quality
E. Efficacy, safety, accessibility
A

Answer: B
Quantitative analysis of drug-receptor interaction trans: The 3 most imporatant properties of drugs are efficacy, safety/lack of toxicity and quality

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30
Q
  1. What are the indices in the graded dose response curve?
    A. Efficacy, potency, slope, variation
    B. Frequency of individual response
    C. Maximum effect, location of the curve on the horizontal axis
    D. A and B
    E. A and C
A

Answer: E
Determinants in the graded-dose response curve are slope, variability, potency, maximal effect/ efficacy, potency. “location of the curve on the horizontal axis” pertains to potency.

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31
Q 
35. The best dose response curve (where it is easiest to analyze mathematically) can be signified by:
A. Sigmoid curve
B. Standing curve
C. Reclining curve
D. Gaussian curve
E. Hyperbolic curve
A

Answer: A
A graded dose response curve plotting log dose against effect produces a sigmoid curve, this is easier to analyze since it produces a shorter horizontal scale.

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32
Q
  1. Antagonism
    A. Is characterized by affinity to a receptor but no intrinsic activity
    B. Can be classified into competitive or irreversible and non-competitive or reversible
    C. Can be classified into competitive or reversible and non-competitive or irreversible
    D. A and C
    E. B and C
A

D

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33
Q
  1. The quantal dose-response curve
    A. Has the shape of a Gaussian or normal curve
    B. Is an all or none curve
    C. Reflects the frequency of population response to drug dose
    D. Reflects the variation of population response to drug dose
    E. AOTA
A

Answer: E
Quantal dose response curve graphs the dose against the population of people producing the desired drug effect, hence an “all or none” event (it’s either you respond to the drug or not). The curve shows both the number and the variation of response of people at different drug concentrations.

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34
Q
  1. Factors that enhance absorption are
    A. Micronization (reducing the size of the particles in a solid drug product)
    B. Mechanisms that lead to the non-ionized moiety (which is the lipoidal form of the drug)
    C. Cardiac output
    D. A and B
    E. B and C
A

Answer: D

Non-ionized, lipid soluble, and small molecules are better absorbed (kinetics 1 trans)

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35
Q
  1. Bioavailability (BA) is a pharmacokinetic parameter that
    A. Can be a measure of quality of a drug product, particularly the generic drugs
    B. Is usually considered under the process of absorption
    C. Is defined as the percentage of the active drug that enters the systemic circulation and its rate of entry
    D. Is performed on certain drug products as benchmarked against the BA of the innovator drug and as required by the FDA now called Bioequivalence Test
    E. AOTA
A

E

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36
Q
  1. Pharmacokinetic parameters in distribution is/are:
    A. Bioavailability and half-life
    B. Protein binding and apparent volume of distribution
    C. Half-life and clearance
    D. A and B
    E. B and C
A

Answer: C

Bioavailability is a parameter of absorption, while half-life and clearance are elimination parameters

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37
Q 
41. Of all the hepatic cytochrome P450 isoenymes, the enzyme responsible for the metabolism of the greatest number of drugs is
A. CYP2D
B. CYP2C
C. CYP3A
D. CYP1A
E. CYD2E
A

C

38
Q
  1. The protein-binding of a drug
    A. Will render the drug inactive
    B. Will enable the drug to cross membranes
    C. Enables the drug to undergo metabolism and excretion
    D. Is subject to competition and would be clinically important across any degree of protein-binding
    E. AOTA
A

Answer: D
Protein bound drug are inactive (in the sense that it can’t reach target cell, but drug itself is not inactive), cannot cross membrane, and are not metabolized at excreted (only unbound drugs undergo elimination). The degree of affinity to protein binding dictates which drug is more protein bound, hence is an important parameter clinically (ie. Less protein bound= higher serum drug concentration)

39
Q 
44. For at least 99% of the drug to be removed from the body after a single dosing under the first-order kinetic reaction, this minimum number of half-lives should have been completed
A. 3 
B. 5
C. 7
D. 9
E. 12
A

Answer: C

By 7 half-lives, 99.2% of the drug has been eliminated

40
Q 
45. This is the most relevant parameter used to assess the extent of the bioavailability for a drug thru a particular route
A. Half-life
B. Cmax
C. Tmax
D. AUC0->t
A

Answer: D

The area under the curve represents the total amount of drug absorbed through a particular route

41
Q
  1. Therapeutically equivalent drugs should have the following characteristic/s
    A. Same configuration, packaging, preservatives, and expiration date
    B. Adequately labeled and manufactured in compliance with current GLP
    C. Safe and effective
    D. AOTA
A

Answer: C
Therapeutically equivalent drugs are pharmaceutical equivalents or alternatives, after administered, produces the same molar dose via the same route, produces the same effects with respect to both efficacy and safety. May or may not be chemically equivalent (differ in color, configuration packaging, preservative, expiration date)

42
Q 
49. Which is not included in an FDA application for approval of a generic drug?
A. Chemistry
B. Animal studies
C. Manufacturing
D. Bioequivalence
A

B. Requirements for generic drug application: chemistry, manufacturing, controls, labeling, testing, bioequivalence.

43
Q 
50. In bioequivalence studies, the following parameters are used to assess the bioavailability of the active ingredient
A. Half-life and Tmax
B. Tmax ¬ and AUCo->t
C. Cmax¬ and Tmax
D. Cmax and AUC0->t
A

Answer: D

Rate and extent of exposure are the most important factors in comparing different formulations (Bioavailability trans)

44
Q
  1. Which is incorrect
    A. Rate of absorption depends on route of administration and drug formulation
    B. Absolute bioavailability of 100 means that a drug is completely absorbed
    C. Relative bioavailability is measured by comparing the respective AUCs after extravascular and intravascular administration
    D. The oral formulation of propranolol that undergoes extensive first-pass metabolism must be administered in a much larger dose than the equivalent IV formulation of the same drug
A

Answer: C
Relative bioavailability compared the BA of a drug to a recognized standard. The definition in C pertains to absolute bioavailability

45
Q

Drug Action and Fate during Special Conditions – GV Dalmacion
52. The following factors affect drug transfer during pregnancy
A. Fetal age
B. Maternal physiologic changes during pregnancy
C. Molecular weight of drugs
D. All of the above

A

Answer: D

Factors affecting drug effects on fetus: pharmacokinetic changes during pregnancy, fetal age, related drug factors

46
Q
  1. The following is true about drug kinetics during pregnancy
    A. The total plasma concentration of albumin bound drugs increase during pregnancy
    B. Free drugs increase during pregnancy but neutralized by increased clearance
    C. Plasma total protein changes significantly during pregnancy
    D. Alpha I glycoprotein protein decreases significantly during pregnancy
A

Answer: B
The total plasma concentration of albumin bound drugs DECREASE during pregnancy due to hemodilution
Plasma TOTAL protein and alpha1 glycoprotein DOES NOT change significantly during pregnancy. Plasma albumin decreases in concentration.

47
Q 
54. Dose adjustment may be needed for anticonvulsants because of the effect of the following on the hepatic metabolizing enzymes
A. Estrogen
B. Prolactin
C. Estrogen and progesterone
D. Progesterone
A

Answer: C
Metabolism of anti-infective, anti-depressants and antiepileptics are changed due to change in the activity of hepatic metabolizing enzymes by estrogens and progesterone. (trans on drug action and fate during special conditions)

48
Q 
55. Crosses the placenta minutes after administration
A. Ampicillin
B. Pen G
C. Phenytoin
D. AOTA
A

Answer: D
Drugs which cross
The placenta in minutes after maternal administration: ampicillin, penG, Cephalothin, kanamycin, tetracycline, sulfonamide, streptomycin, diazepam, bupivacaine, phenytoin, barbiturates, ethanol, meperidine, salicylate, propranolol

49
Q
  1. This drug has been classified under Category C
    A. Omeprazole
    B. Ranitidine
    C. Metoclopramide
A 
Answer: A
Category A: folic acid
Category B: ranitidine, metoclopramide
Category C: omeprazole, domperidone
Category D: etoposide, bleomycin, aspirin
Category X: enalapril
50
Q 
57. Drugs that reach the embryo before the 20th day will have the following effect
A. Normal growth or abortion
B. Altered growth
C. Covert embryopathy
D. Sublethal anatomic defect
A

Answer: A

All or nothing effect before the day 20

51
Q 
58. Most affected pharmacokinetic property in parenchymal liver disease
A. Absorption
B. Distribution
C. Metabolism
D. Excretion
A

C. Drug metabolism occurs in the liver

52
Q 
59. The extent to which a drug is cleared in one passage in the liver is
A. pKa
B. Extraction ratio
C. Liberation
D. NOTA
A

Answer: B

Extraction ratio is the extent to which a drug is cleared in one passage in the liver

53
Q 
60. There is prolongation of half-life of this drug among patients with liver parenchymal disease
A. Tolbutamide
B. Ampicillin
C. Acetaminophen
D. Digoxin
A

Answer: C
Prolonged half life: acetaminophen, carbenicillin, chloramphenicol, clindamycin, rifampicin, isoniazid, lidocaine, meperidine, phenobarbital, diazepam, theophylline

54
Q 
61. An antibiotic which induces its own hepatic metabolism
A. PAS
B. INH
C. Rifampicin
D. Tolbutamide
A

Answer: C

Rifampicin is an enzyme inducer and is able to induce its own metabolism

55
Q
  1. The following are conditions for the validity of the dose adjustment for patients with… EXCEPT
    A. There is a relationship between creatinine clearance and renal elimination of the drug
    B. Unstable renal function
    C. The drug follows first order kinetics
    D. No alteration of drug sensitivity
A

Answer: B
Conditions for the validity of DAF (Dosage adjustment factor)
• Only for first order kinetics in the therapeutic concentration range
• Metabolites of the drug are not active and non-toxic
• No difference in the absorption, distribution and metabolism of the drug between normal and uremic patients
• No alterations in drug sensitivity in uremic patients
• Direct relationship assumed between ClCr and the renal elimination of the drug
• Stable kidney function

56
Q 
63. The most widely used test for renal function is GFR and reflects the following:
A. Creatinine clearance
B. Renal absorption
C. Renal secretion
D. AOTA
A

Answer: A
The most widely used test of renal function is the glomerular filtration rate which is commonly approximated as the creatinine clearance (trans)

57
Q
  1. Whether a patient with renal disease requires dose adjustment depends on
    A. The therapeutic index of the drug
    B. The proportion of renal clearance to the total clearance of the drug
    C. Severity of renal impairment
    D. AOTA
A

Answer: D
Factors determining requirement for dosage adjustment
• Therapeutic index of drug
• Proportion of renal clearance to total clearance of the drug
• Severity of renal impairment

58
Q

True or false

66. Oral bioavailability is dependent on liver and renal metabolism

A

Answer: FALSE
Bioavailability is a measure of drug absorption, may be affected by first pass metabolism but not by renal metabolism/clearance

59
Q
  1. Noncompartmental analysis is appropriate only for 1-compartment model
A

Answer: False

Non-compartmental analysis holds no assumptions in the compartmentalization of drug distribution

60
Q
  1. The intravenous route is considered 100% absorption
A

Answer: TRUE

Since all of the drug administered enters the systemic circulation

61
Q
  1. Oral and IV AUC are adequate to compute for oral bioavailability provided that the doses are the same
A

Answer: TRUE

absolute bioavailabity equation

62
Q
  1. The most important of the CYP450 enzymes is CYP3A4 because it metabolizes 33% of all drugs that are metabolized.
A

TRUE

63
Q
  1. For a drug that behaves in a linear fashion, doubling the dose would mean doubling the Cmax and AUC
A

Answer: TRUE

In first order reactions, rates are linearly related to dose administered.

64
Q
  1. If the Ka is increased, absorption is faster and Cmax will be attained earlier
A

Answer: TRUE

An increase in Ka (rate of absorption), will lead to a lower Tmax—hence faster absorption and Cmax reached earlier

65
Q
  1. In a one-compartment model with first order input and first order elimination, absorption stops when Cmax is reached
A

FALSE. Once Cmax is reached, absorption does not stop, it’s just that Ke>Ka  rate of elimination is faster than absorption, hence the graph starts to go down

66
Q
  1. For a first-order, two compartment equation, distribution is immediate and instantaneous within the same compartment
A

Answer: FALSE
In a 2-compartment model, the distribution phase from the central to the peripheral compartment is signified by the steeper initial slope of the graph, hence it’s not immediate.

67
Q
  1. If there is a change in plasma protein binding, the impact will be greater in a drug that is more highly protein-bound than one which is less protein-bound
A

Answer: TRUE
Scenario where there is 1% decrease in protein binding:
99% protein bound- from 1% free drug becomes 2% which is a 100% increase
90% protein bound- from 10% free drug becomes 11% which is a 10% increase

68
Q
  1. Absolute bioavailability always varies from 0 to 1
A

Answer: TRUE

It’s a ratio between BA in oral and IV administration

69
Q
  1. Vd should always match actual body fluid compartments
A

Answer: FALSE

Volume of distribution is a hypothetical volume, hence it can be larger than actual body fluid volumes

70
Q
  1. The therapeutic margin ranges from the minimum therapeutic concentration to the maximum therapeutic concentration.
A

Answer: FALSE

Aka therapeutic index: ratio of the minimum toxic dose, and the minimum effective dose

71
Q
  1. Increasing dosage will always increase therapeutic effect.
A

Answer: FALSE
When ceiling dose is reached, increased dose will not result to increased response (hyperbolic graded dose-response curve)

72
Q
  1. Regardless of the number of compartments, when the equilibrium is reached, the whole system behaves like a one compartment model
A

Answer: TRUE

When the drug distribution to all compartments reaches equilibrium, it acts like a one compartment model

73
Q
  1. The purpose of metabolism is to convert the drug into a more polar form and make them more excretable by the kidneys
A

Answer: TRUE

74
Q
  1. A drug that is highly protein-bound would have a high volume of distribution
A

Answer: FALSE. A highly protein bound drug stays intravascularly, hence Vd will be limited to the intravascular blood volume.

75
Q
  1. After giving a drug repeatedly for 8 half-lives, we are confident that it is in steady state concentration
A

Answer: TRUE

Steady state is achieved after 4-7 half lives

76
Q 
84. The half-life of a drug is 8 hours. What is the plasma drug concentration after 24 hours if the current concentration is 100 pmol/L?
A. 25 pmol/L
B. 16.33 pmol/L
C. 12.5 pmol/L
D. 6.25 pmol/L
E. 3.125 pmol/L
A 
Answer: C
In 24 hours= 3 half lives. 
After 1st 8 hours= 50 pmol/L
After 2nd 8 hours= 25 pmol/L
After 3rd 8 hours= 12.5 pmol/L
77
Q 
85. If clearance is reduced by 50% and volume of distribution is doubled, half-life is equivalent to
A. Reduced by 75%
B. Increased by 1.33x
C. Increased by 4x
D. No change
A

Answer: C
t ½ = 0.693Vd/ Cl
t ½ = 0.693 (2) Vd/ 0.5Cl
t ½ = 4(0.693Vd/ Cl)

78
Q
  1. What happens to bioavailability as the dose increases when there is saturable liver metabolism?
    A. Increase
    B. Decrease
    C. Remains the same
A

Answer: A
When first pass metabolism has been saturated, the additional dose will not undergo first-pass anymore, hence BA increases

79
Q
  1. What happens to clearance as the dose increases when there is saturable liver metabolism?
    A. Increase
    B. Decrease
    C. Remains the same
A

Answer: B
Clearance is the quantification of elimination (metabolism + excretion), so with a saturable metabolism, clearance will decrease in increased dosing

80
Q
  1. What happens to bioavailability as the dose increases when there is saturable renal absorption?
    A. Increase
    B. Decrease
    C. Remains the same
A

Answer: C

BA is not affected by renal absorption

81
Q
  1. What happens to bioavailability as the dose increases when there is saturable dissolution?
    A. Increase
    B. Decrease
    C. Remains the same
A

Answer: B
Drug dissolution is necessary for drug absorption so a saturable dissolution rate will decrease the bioavailability of the drug

82
Q 
92. 2.4 g in 1 day required, maximum of 17 hours dosing interval. What dosing will you use?
A. 800 mg in 8 hours
B. 1.2 g in 12 hours
C. 1.6 g in 16 hours
D. AOTA
E. A and B only
A

Answer: E

With C, after 24 hours, the patient is only received 1.6g

83
Q 
93. Formula for half-life in first order kinetics
A. Vd/CL
B. (VD x ln 2)/CL
C. (CL x ln 2)/ VD
D. ln 2 / (0.693 x k)
A

B

84
Q
  1. Non-clinical testing of drugs
    A. Apply to in-vivo or in-vitro experiments in which the test article
    B. Include studies utilizing human beings
    C. Are concerned only with studies in animals prior to clinical drug trials
    D. AOTA except C
A

Answer: A

Non-clinical testing also involves determining the chemical properties of the drug

85
Q
  1. FDA Act of 2009 defines drugs as
    A. Articles intended to affect the structure of any function of the body
    B. Articles intended for use in the diagnosis, cure, mitigation, and treatment of man or other animals
    C. Include food supplements, devices, or their components, parts , etc.
    D. A and B only
A

Answer: D
(1) articles recognized in official pharmacopoeias and formularies, including official homeopathic pharmacopoeias, or any documentary supplement to any of them; which are recognized and adopted by the FDA; (2) articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; (3) articles(other than food) intended to affect
The structure of any function of the body of humans or animals; or (4) articles intended for use as a component of any articles specified in clauses (1), (2) or (3) but do not include devices or their components, parts, or accessories.

86
Q
  1. Herbal medicines defined in the TAMA law to include the following statements, except
    A. Are finished labeled product containing parts of plants (underground roots, etc)
    B. Combined with chemically defined active substances or isolated concentrates
    C. May contain excipients in addition to active ingredients
    D. Herbal medicines may be in the crude state or plant preparations
A

Answer: B
Herbal medicine is defined as finished, labeled medicinal products that contain as active ingredients, aerial or underground part/s of plant or other materials or combination thereof; whether in the crude state or as plant preparations. It may contain excipients in addition to active ingredients. Whenever any synthetic or pure chemical is present as an active ingredient in an herbal preparation, that is not a herbal medicine

87
Q
  1. The required standard of the Philippine FDA for herbal medicine include:
    A. Limit test for Arsenic of
A

Answer: B

Limit for Arsenic

88
Q
  1. The single dose (Phase 1 human studies) require data on
    A. 2 weeks of repeated dose toxicity studies in rodents only
    B. 3 month repeated dose toxicity studies and one month repeated dose toxicity studies in non-rodents
    C. Repeated dose toxicity studies of 2 weeks in rodents and non-rodents
    D. Repeated dose chronic toxicity studies in rodents
A 
Answer: A
Single dose (to support Phase 1 human) studies requires data on at least 2 weeks of repeated dose toxicity studies on rodents or non-rodents
89
Q
  1. In the US, women of child-bearing potential may participate in clinical studies provided appropriate measures to minimize risk and require the following
    A. There is completed assessment of female fertility and embryo fetal development in non-rodents
    B. Completed reproduction studies in rodents and non-rodents
    C. Completed battery of genotoxicity test
    D. B and C only
A

Answer: D
Completed assessment of female fertility and embryo fetal development are required in phase 3 trials for women using highly effective birth control. There should also be completed reproductive toxicity studies and standard battery of genotoxicity tests prior to inclusion in any clinical trial of women of child bearing potential not using highly effective birth control or whole pregnancy status is unknown

90
Q
  1. The general principles of the Guidelines for Non-Clinical Safety Studies include
    A. Characterization of toxic effects with respect to target organ
    B. Establishment of safety pharmacology by toxicity studies, assessment of vital functions
    C. Case by case approach to assessment of phototoxicity, immunotoxicity, juvenile animal toxicity, and abuse liability
    D. AOTA
A

D

91
Q

What do you prescribe to a patient with bronchoconstrictioin?
A. beta-blocker
B. beta-agonist

A

Answer: B

Beta agonists such as salbutamol

92
Q 
80% 80 mg 8 hour, 60 ClCr
A drug is excreted 80% unchanged. Given 80 mh 18 hours to patient with 60 ClCr. What is DAF?
A. 0.7
B. 1.7
C. 2.5
D. 3.5
A 
Answer: B
F= fraction of drug excreted unchanged
Kf=relative kidney function calculated by dividing the actual or derived ClCr with 120ml/min
DAF= 1/ [F(kf-1)+1]
= 1/ [0.80(60/120 -1)+1]
1.7

[FINALS] LU4 2018 (9 decks)

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