ASPECTS OF PHARMACOTHERAPY, CLINICAL PHARMACOLOGY AND DRUG DEVLOPMENT
TOP 10 MCQ
1. When is a New Drug Application (NDA) made [GPAT-2023 SHIFT-I]
(a) Once the animal studies are done and drug is declared safe in animals
(b) Once the animal studies are done and drug is declared safe and effective in animal studies
(c) After the phase III clinical trials
(d) After the phase IV clinical trials
2. Match the following phases of clinical trial with their significance
  List I                   List II
 Phase-I        [P] Post marketing surveillance
 Phase-II       [Q] Microdosing
 Phase-III      [R] First in human dose
 Phase-IV      [S] Multicentric trials
Choose the correct answer from the options given below [GPAT-2022]
(a) 1-[R], 2-[Q], 3-[P], 4-[S]
(b) 1-[R], 2-[Q], 3-[S], 4-[P]
(c) 1-[Q], 2-[S], 3-[P], 4-[R]
(d) 1-[S], 2-[P], 3-[Q], 4-[R]
3. The objective of the Abbreviated New Drug Application is to [GPAT-2022]
(a) Get approval to conduct clinical trials
(b) Get market approval of new chemical entities
(c) Get market approval of generics
(d) Get approval for animal studies of new chemical entities
4. To monitor the safety of the new drug under actual conditions of use in large number of patients has been classified as Clinical trials [GPAT-2021]
(a) Phase III
(b) Phase II
(c) Phase IV
(d) Phase I
5. Identify phase of clinical trial having following features [GPAT-2020]
[P] Trial is conducted on about 3000 patients
[Q] Purpose of trial is therapeutic confirmation
[R] Safety and tolerability is evaluated on wider scale
[S] Completion of trial is followed by New Drug Application (NDA)
(a) Phase III
(b) Phase I
(c) Phase IV
(d) Phase II
6. The number of subjects required in a phase I clinical trial is [GPAT-2018]
(a) 20 to 100
(b) Up to several hundred
(c) 300 to 3,000
(d) Several thousands
7. Phase 0 studies means [GPAT-2017]
(a) In vitro studies
(b) Part of phase I studies of clinical trials
(c) First in human microdosing studies
(d) Studies carried out on small number of animals
8. In which of the following phases of clinical trials, healthy normal human volunteers participate [GPAT-2016]
(a) Phase I
(b) Phase II
(c) Phase III
(d) Phase IV
9. Following are the phases of clinical trials [GPAT-2012]
[P] Human pharmacology
[R] Post marketing trials
[Q] Therapeutic confirmatory trials
[S] Therapeutic exploratory trials
Choose the correct order of phases of clinical trial
(a) P, Q, R, S
(b) P, R, Q, S
(c) P, Q, S, R
(d) P, S, Q, R
10. Geriatric populations should be included in the following phase of clinical trials [GATE-2010]
(a) Phase I
(b) Phase II
(c) Phase III
(d) Phase IV
ANSWER KEY
| 1-c | 2-b | 3-c | 4-c | 5-a | 6-a | 7-c | 8-a | 9-d | 10-d |
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