Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

PHA337 > Bioequivalence > Flashcards

Bioequivalence Flashcards

1
Q

Which of the following will have the slowest bioavailability rate?

A. Tablet
B. Solution
C. Suspension
D. Coated tablet

A

D. Coated tablet

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

The relative amount of the administered dose that reaches general circulation and the rate at which it dose so is defined as:

A. Bioavailability
B. Therapeutic equivalence
C. Pharmaceutical alternative
D. Bioequivalence

A

A. Bioavailability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

Compares IV administration to another dosage form is:

A. Chemical equivalence
B. Absolute bioavailability
C. Relative bioavailability
D. Therapeutic equivalence

A

B. Absolute bioavailability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

Which is a physiologic factor that influence bioavailability?

A. Excipient
B. Crystal polymorph
C. Gastric emptying
D. Particle size

A

C. Gastric emptying

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
5
Q

All the following are methods to assess bioavailability EXCEPT:

A. Computational calculation
B. Acute pharmacodynamic effect
C. Plasma drug concentration
D. Urinary drug excretion data

A

A. Computational calculation

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
6
Q

Two products have the same API but different crystal form and also different release pattern is defined as:

A. Bioequivalence
B. Chemical equivalence
C. Pharmaceutical alternative
D. Therapeutic equivalence

A

C. Pharmaceutical alternative

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
7
Q

Pharmaceutical alternative is defined as:

A. Two products contain same amount of API, purity, same type dosage
B. Two products have the same API but crystal form may vary (Salt, ester, etc.)
C. Two products have similar bioavailability, AUC, Cmax, Tmax.
D. Two products have the same toxic or therapeutic effectiveness

A

B. Two products have the same API but crystal form may vary (Salt, ester, etc.)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
8
Q

Which dosage form will have fastest bioavailability?

A. Tablet
B. Solution
C. Coated tablet
D. Suspention

A

B. Solution

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

Bioavailability that compares two dosage forms, Cmax and tmax is:

A. Absolute
B. Relative bioavailability
C. Bioequivalence
D. Bioavailability

A

B. Relative bioavailability

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

Which is the formulation factors control bioavailability?

A. Gastric emptying
B. Intestinal motility
C. Change in GIT pH
D. Particlesize of API

A

D. Particlesize of API

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
11
Q

All the following must be considered to design a drug product EXCEPT:

A. Biopharmaceutics factors
B. Finance factor
C. Pharmacodynamic factors
D. Pharmacokinetics of drug

A

B. Finance factor

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
12
Q
  1. What is bioequivalence?

A. Comparison between 3-year-old drugs to the same new drug
B. Comparison between drugs to another drug
C. Comparison between a drug’s specific characteristics to a defined set of standards
D. Comparison between two or 3 characteristics of a drug to the same characteristics of a different drug

A

C. Comparison between a drug’s specific characteristics to a defined set of standards

Explanation: Bioequivalence is a relative term which compares drug products with respect to specific characteristics or function to a defined set of standards. There are several types of bioequivalence such as chemical equivalence, pharmaceutic equivalence, bioequivalence, therapeutic equivalence.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q
  1. What is the chemical equivalence?

A. Two or more drug products contain the same labeled chemical substance in the same amount
B. Two or more drug products contain the same labeled chemical substance in different quantity
C. Two or more drug products contain different labeled chemical substance giving the same therapeutic effect.
D. Two or more drug products contain the same labeled chemical substance giving a different therapeutic effect

A

A. Two or more drug products contain the same labeled chemical substance in the same amount

Explanation: Chemical equivalence of drug products is said when the drugs contain the same active ingredient. The amount of the active ingredient must be the same. When two or more drug products contain the same active ingredient giving the same pharmacologic effect is known as therapeutic equivalence.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
14
Q

Bioequivalence is a relative term which denotes that the drug substance reaches the systemic circulation at the same relative rate or time.

A. True
B. False

A

A. True

Explanation: Bioequivalence is a relative term which denotes that the drug substance reaches the systemic circulation at the same relative rate or time and to the same extent when given in two or more identical dosage. That is their plasma level concentration-time profile will be identical without significant statistical differences. When statistically significant differences are observed in the bioavailability of two or more drug products, bioequivalence is shown.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
15
Q
  1. What is therapeutic equivalence?

A. Two or more drug products contain the same labeled chemical substance in the same amount
B. Two or more drug products contain the same labeled chemical substance in different quantity
C. Two or more drug products contain the same labeled chemical substance giving the same therapeutic effect
D. Two or more drug products contain the same labeled chemical substance giving a different therapeutic effect

A

C. Two or more drug products contain the same labeled chemical substance giving the same therapeutic effect.

Explanation: When two or more drug products contain the same therapeutically active ingredient which elicits the same pharmacological effects and can control the disease to the same extent are known to have therapeutic equivalence. Bioequivalence is a relative term which denotes that the drug substance reaches the systemic circulation at the same relative rate or time and to the same extent when given in two or more identical dosage.

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

Intravenously administered

A

F= 1.0 (100% drug gets into the blood).

Examples: Vancomycin and aminoglycosides IV: F = 1.0

17
Q

Bioavailability Fraction

A

The fraction of the drug that is absorbed from gastro-intestinal tract and the fraction that escapes metabolism during its fast pass through the liver.

18
Q

Extravascular administered

A

F = anything from 0.0 to 1.0 (not many with 1)

Examples: Vancomycin po: F = <0.05, Theophylline po: F = 0.9 -1.0, Zopiclone po: F = 0.75

19
Q

Two products have similar biovailability when administered in the same manner. Same AUC, Cmax, tmax.

A. Absolute bioavailability
B. Bioequivalence
C. Pharmaceutical alternative
D. Therapeutic equivalence

A

B. Bioequivalence

20
Q

Therapeutic equivalence means that two products have the same toxic or therapeutic effectiveness.

A. True
B. False

A

A. True

21
Q

Two products have the same API but crystal form may vary (SALT, ESTER etc.)

A. Therapeutic equivalence
B. Relative Bioavailability
C. Pharmaceutical equivalence
D. Pharmaceutical alternative

A

D. Pharmaceutical equivalence

22
Q

Pharmaceutical alternative means two products contain the same amount of API are the same type of dosage form and have the same API purity, content uniformity as well as the same disintegration.

A. True
B. False

A

B. False

Because is Pharmaceutical or chemical equivalence

23
Q

Compares IV administration to another dosage form.

A

Absolute bioavailability

24
Q

Compares two dosage forms.

Cmax and tmax must also be compared

A

Relative Bioavailability

25
Q

Disintegration rate (tablets), dissolution time of drug in dosage form, product and storage condition.

A

Dosage form characteristics

26
Q

Factors that influence bioavailability: (6)

A
  1. Formulation factors
  2. Physiological factors
  3. Physics-chemical properties
  4. Pharmaceutical ingredients
  5. Dosage form characteristics
  6. Physiologic factors and patient characteristics
27
Q

Particle size, crystalline or amorphous form, salt form, hydration, pH, pK.

A

Physico-chemical properties of drug

28
Q

Filler, binder, coating, disintegrating agent, lubricants, surfactants, coloring/flavoring agent.

A

Pharmaceutical ingredients

29
Q

Gastric emptying time, intestinal transit time, other drug effect, food (e.g.,grapefruit juice), fed or fast condition, fluids, Gastrointestinal pH, drug metabolism

A

Physiologic factors and patient characteristics

30
Q

What are this type of factors?

Gastric emptying
Intestinal motility
Changes in gastrointestinal pH
Changes in nature of intestinal wall

A

Physiological factors

31
Q

What are this types of factors?

Excipients (type and amount)
Particle size of API
Crystal polymorph
Hydrate or solvate

A

Formulation factors

32
Q

Which of these are methods for assessing bioavailability? Select all that apply.

A. Plasma drug concentration
B. In vitro studies
C. Clinical observation
D. Dosing frequency 
E. Acute pharmacodynamic effects
A

A. Plasma drug concentration
B. In vitro studies
C. Clinical observation
E. Acute pharmacodynamic effects

33
Q

What are these?

Plasma drug concentration
Urinary drug excretion data
Acute pharmacodynamic effects
Clinical observation
In vitro studies

A

Methods for assessing bioavailability

34
Q

Which of these is not a factor that must be considered to design a drug product? Select all that apply

A. Biopharmaceutics factors
B. Pharmacodynamics factors
C. Drug substances 
D. Pharmacokinetics of drug
E. In vitro studies 
F. Bioavailability of drug
G. Dose considerations 
H. Dosing frequency 
I. Patient consideration
J. Route of administration 
K. Clinical observation
A

E. In vitro studies

K. Clinical observation

35
Q

What they all have in come?

  1. Biopharmaceutics factors
  2. Pharmacodynamics factors
  3. Drug substances
  4. Pharmacokinetics of drug
  5. Bioavailability of drug
  6. Dose considerations
  7. Dosing frequency
  8. Patient consideration
  9. Route of administration
A

Considerations in the design of a drug

36
Q

Drug products considerations:

A
  1. Oral drug product
  2. Absorption of Lipid-soluble drugs
  3. Gastrointestinal-intestinal side effect
  4. Immediate release and modified release drug products
  5. Buccal and sublingual Tablets
  6. Colonic drug delivery
  7. Rectal and vaginal drug delivery
  8. Parenteral Drug Products
37
Q

The biopharmaceutical considerations in drug products design includes?

A
  1. Studies done to decide the physiochemical nature of the drug to be used, for example, salt and particle size.
  2. The timing of these studies in relation to the preclinical studies with the drug
  3. The determination of the solubility and dissolution characteristics the evaluation of drug absorption and physiological disposition studies
  4. The design and evaluation of the final drug evaluation.

PHA337 (5 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2024 Bold Learning Solutions. Terms and Conditions