BIOAVAILABLITY AND BIOEQUIVALENCE
TOP 10 MCQ
1. Which type of in-vitro–in-vivo correlation compares % drug released vs % drug absorbed [GPAT-2023 SHIFT-II]
(a) Level C
(b) Level A
(c) Multiple level C
(d) Level B
2. Under which of the following conditions in-vitro–in-vivo correlation for a drug fails [GPAT-2023 SHIFT-II]
(a) When the dissolution medium is adequately simulated
(b) When the drug’s absorption takes place by a complex process
(c) When the drug is highly soluble
(d) When the drug is highly permeable but poorly soluble
3. Ideally BA studies should be carried on ______ volunteers [GPAT-2023 SHIFT-II]
(a) Aged
(b) Children
(c) Patient
(d) Healthy
4. Match List-I with List-II [GPAT-2022]
             List-I                                         List-II
When two dosage forms have equal tmax       [P] When their total body clearance is constant
AUC values of the two analogs can be          [Q] Absorption compared rate constants are to bioavailability equal measure relative
Urinary data is valid to measure bioavailability  [R] When fraction absorbed and elimination rate is constant
Cmax is proportional to the rate of absorption  [S] Excretion of drug and/or metabolite is related to the bioavailable dose
Choose the correct answer from the options given below
(a) 1-[Q], 2-[P], 3-[S], 4-[R]
(b) 1-[P], 2-[Q], 3-[R], 4-[S]
(c) 1-[P], 2-[S], 3-[R], 4-[Q]
(d) 1-[R], 2-[P], 3-[Q], 4-[S]
5. For depot injections, in which drug is slowly released over weeks or months, which bioequivalence study design is used [GPAT-2021]
(a) Multiple dose study design
(b) Replicated crossover study design
(c) Non-replicate, parallel study design
(d) Randomized crossover design
6. For drug substances with highly variable pharmacokinetic characteristics the following Bioequivalence study design is used [GPAT-2019]
(a) Parallel Design
(b) Non-Replicate Design
(c) Non-Parallel Design
(d) Replicate Design
7. The Co-administration of Erythromycin with Cyclosporine [GPAT-2019]
(a) Increase bioavailability, due to inhibition of hepatic metabolism
(b) Increase bioavailability, due to inhibition of microflora in intestine
(c) Decrease bioavailability due to complex formation
(d) Decrease bioavailability, due to induction of hepatic metabolism
8. When two brands of a drug product gives same clinical results, it is termed as [GPAT-2019]
(a) Therapeutic equivalence
(b) Bio equivalence
(c) Pharmaceutical equivalence
(d) Clinical equivalence
9. IVIVC utilizes the principles of statistical moment analysis [GPAT-2018]
(a) Level A
(b) Level B
(c) Level C
(d) Level D
10. The useful variable from in vitro dissolution test data for IVIVC includes [GPAT-2017]
(a) t50% – t63.2%
(b) Sampling interval
(c) Sample volume
(d) Volume of dissolution fluid
ANSWER KEY
| 1-b | 2-c | 3-d | 4-a | 5-c | 6-d | 7-a | 8-a | 9-b | 10-a |
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