Dr.A.P.J.Abdul Kalam University Old Question Papers
Bachelor of Pharmacy
Eighth Semester Main Examination, Aug-Sep 2020
Pharmaceutical Regulatory Science [BP804ET]
Time: 3:00 Hrs Max Marks 75
Note : (i) All parts of the question paper are compulsory.
(ii) All question of each part to be attempt at one place.
Part-A
Q.1 Multiple choice questions- [1x20 = 20 Marks]
(xxi) How many people will be selected for phase I trial?
(a) The whole market will be under surveillance
(b) 300-3000 people
(c) 20-300 people
(d) 20-50 people
(xxii) What is meant by a blind subject?
(a) The subjects do not know which study treatment they receive
(b) Patients injected with placebo and active doses
(c) Fake treatment
(d) Signed document of the recruited patient for the clinical trial procedures
(xxiii) What is informed consent in a clinical trial?
(a) The subjects do not know which study treatment they receive
(b) Patients injected with placebo and active doses
(c) Fake treatment
(d) Signed document of the recruited patient for the clinical trial procedures
(xxiv) Which one of the following is the last step of a clinical trial process?
(a) Investigator selection (b) Patient recruitment
(c) Statistical Analysis (d) Data filed and registration
(xxv) The first step of rational drug design is to _____.
(a) Identify the target molecule
(b) Characterize the shape of the target molecule
(c) Design a drug for the target molecule
(d) Test the drug molecule
(xxvi) The null hypothesis
(a) Is the opposite of the research hypothesis.
(b) provides, when rejected, support for the research hypothesis.
(c) Is a tool in the reasoning process.
(d) All of the above.
(xxvii) Document mandatory to enroll subject in clinical research study?
(a) Protocol (b) Case Report Form
(c) Informed Consent Form (d) Investigators Brochure
(xxviii) In how many phase clinical research study is conducted?
(a) 5 (b) 4
(c) 8 (d) 1
(xxix) To begin clinical research study it is mandatory to get approval from?
(a) Sponsor
(b) Scientist
(c) Regulator
(d) Regulators and ethics committee both
(xxx) Whose responsibility is to prepare essential documents like protocol/ investigators brochure/ informed
consent form/ case report form in clinical trials?
(a) Investigator (b) Ethics committee
(c) Scientist (d) Sponsor
(xxxi) After complete absorption of drug it move into the various processes such as:
(a) Distribution and protein binding
(b) Biotransformation of drug and excretion
(c) Both a and b
(d) None of these
(xxxii) The main features of this transport system is:
(a) Transport occurs along the concentration gradient.
(b) No energy expenditure is involved.
(c) Transport is saturable, and competition occurs between isomers.
(d) All of these
(xxxiii) The intensity of pharmacological effect is normally a function of the:
(a) pH of the drug
(b) Solubility
(c) Concentration of drug achieved in the circulation
(d) None of above
(xxxiv) Movement of ions through the pores in cell membrane can be controlled by:
(a) Counter ion transport
(b) Expenditure of intracellular energy
(c) Both A&B
(d) None of these
(xxxv) The onset of drug action depends on the rate of:
(a) Drug absorption
(b) Drug dissociation
(c) Both A & B
(d) None of these
(xxxvi) Which of the following are not correct on the basis of clinical trials?
(a) Biomedical research studies
(b) Behavioral research studies
(c) Studies on human subjects
(d) Study based only on animals
(xxxvii) What do you mean by a randomized design?
(a) The subjects do not know which study treatment they receive
(b) Patients injected with placebo and active doses
(c) Randomly assigning subjects either for placebo or active dose
(d) Signed document of the recruited patient for the clinical trial procedures
(xxxviii)What is placebo?
(a) The subjects do not know which study treatment they receive
(b) Patients injected with placebo and active doses
(c) Fake treatment
(d) Signed document of the recruited patient for the clinical trial procedures
(xxxix) Which one of the following is the last step of a clinical trial process?
(a) Investigator selection
(b) Patient recruitment
(c) Statistical Analysis
(d) Data filed and registration
(xl) Which one of the following will be checked under phase IV surveillance?
(a) The whole market will be under surveillance
(b) 300-3000 people
(c) 20-300 people
(d) 20-50 people
Part-B
Short answer type question [5x7 = 35 Marks]
Note : Attempt any Five questions, all question carry equal marks
Q.1 Give the brief knowledge of regulatory requirement for approval of new drugs.
Q.2 Explain in brief concept of generic product development.
Q.3 Short note on common technical documentation.
Q.4 Give detail note on DMF (Drug Master File).
Q.5 Give short note on INDA and ANDA.
Q.6 Explain in brief concept of generic product development.
Q.7 Explain in flow chart form drug approval process and timelines involved in the new drug application
Part-C
Long answer type question [10x2 = 20 Marks]
Note : Attempt any TWO questions, all question carry equal marks
Q.1 Give various stages of drug discovery and development process.
Q.2 Define in detail pre-clinical and non-clinical studies.
Q.3 Give various stages of clinical trial and how much volunteers involved on each trial
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