Drug Biotechnology Multiple Choice Questions on “Bioequivalence Studies”.
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
Answer: c
Clarification: 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.
2. 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
Answer: a
Clarification: 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.
3. What is pharmaceutic equivalence?
a) Two or more drug products contain the same labeled chemical substance in the same amount
b) Two or more drug products are identical in quality, purity, uniformity, disintegration, dissolution
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
Answer: b
Clarification: Pharmaceutic equivalence implies that two or more drug products when they are identical in strength, purity, content uniformity, and disintegration and dissolution characteristics. Though the excipients may differ. 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.
4. What is bioequivalence?
a) Drug substance reaches the systemic circulation at the same rate in two or more identical dosage
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
Answer: a
Clarification: 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.
5. 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
Answer: c
Clarification: 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.
6. On which individuals study of newly invented medicines are not done?
a) Pregnant and elderly
b) Fasting person
c) Healthy person
d) Adult male
Answer: a
Clarification: Drug studies are performed on fasting, young, healthy, adult male volunteers to assure homogeneity in the population. They spare the patients, elderly and pregnant women from such clinical investigations. Homogeneity on the population helps in studying the formulation factors.
7. What should be the disadvantage of cross over study on volunteers?
a) Minimize the intersubject variability in plasma drug levels
b) Minimize the carry-over effect
c) Minimizes variations due to time effect
d) Takes a lot of time to get the result of the study
Answer: d
Clarification: The advantages of randomized, balanced, cross-over study is it minimizes the intersubject variability in plasma drug levels, minimize the carry-over effect, minimizes variations due to time effect, makes it possible to focus on formulation variables. But this method takes a long time because a specific time has to be given for the washout of the previous administration.
8. Two or more drugs contain the same therapeutically active ingredient which elicits same pharmacological effects and can control the disease to the same extent are known to be pharmaceutic equivalent.
a) True
b) False
Answer: b
Clarification: 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. Pharmaceutic equivalence implies that two or more drug products when they are identical in strength, purity, content uniformity, and disintegration and dissolution characteristics.
9. If the bioavailability of test formulation is 80-120% of the reference standard, it is considered to be bioequivalent.
a) True
b) False
Answer: a
Clarification: A significant difference of 10% in the extent of absorption between the two formulations is clinically insignificant. Thus, a rule is that if the relative bioavailability of the test formulation is in the range 80-120% 0f reference standard, it is considered to be bioequivalent.
10. 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
Answer: a
Clarification: 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.