B.Pharmacy III (Semester VI) (CGPA Pattern) Examination, 2018
Clinical Pharmacology
Day and Date Friday, 18-5-2018 Max. Marks 70
Time 10.30 a.m. to 1.30 p.m.
1. MCQ (1×15=15)
Obesity affect pharmacokinetic and pharmacodynamics of sedative agent due to which of following
Decrease in lean body mass
Increase in glomerular filteration rate
Increase in cardiac output
Increase in plasma protein binding
Down regulation of receptor can occur as a consequence of
Continuous use of agonist
Continuous use of antagonist
Chronic use of CNS depressant
None of above
High clearance drug are
Depend on blood flow Not depend on blood flow
Depend on bile flow Not depend on bile flow
Microsomal enzyme induction can be a cause of
Tolerance Physical dependence
Psychological dependence Idiosyncrasy
The side effect of drug which has been used as therapeutic effect in another condition is
Constipation caused by codeine
Cough caused by captopril
Uterine stimulation caused by quinine
Diarrhea caused by ampicillin
Set
P
Seat
N
o.
Set P
SLR-TA 43 *SLRTA43*
Which of the following is the type B (Unpredictable) adverse drug reaction
Side effect Toxic effect
Idiosyncrasy Physical dependence
Which of the following is not one of the principles set forth in the Belmont Report
Justice Beneficience
Freedom Respect of person
Microdosing studies are done before start of
Phase I Phase II Phase III Phase IV
What is the purpose of phase I clinical trials
To select a lead compound from lead series
To identify a target population
To establish the safety of administration to humans
To test whether the proposed drug actually works
10) Prior to subject participation in the trial, the should be signed and personally dates by the subject.
Protocol Clinical trail agreement
IRB approval report Written informed consent form
11) The major purpose of Randomization in clinical trials is to
Facilitate double blinding
Help ensure that study subject are representative of general population
Reduce selection bias in allocation of treatment
None of above
12) The null hypothesis
Is the opposite of research hypothesis
Provides, when rejected, support for the research hypothesis
Is a tool in the reasoning process
All of above
Set P
*SLRTA43* SLR-TA 43
13) The period of pregnancy during which drug administered to mother result in either all or none response
Conception to 17 day of gestation
18 to 55 days of gestation
56 days onwards
None of above
14) What do you mean by poly pharmacy
Many drugs prescribed in patients
Drugs taken from many pharmacies
Drugs prescribed in many patients
None of above
15) Pharmacovigilance is relating to detection, assessment, understanding and prevention of
Adverse effect Drug interaction
Unethical practice None of above
2. Answer any five
Explain in detail Nuremberg code.
Define side effect, Idiosyncrasy, Teratogenicity, Supersensitivity and Intolerance with example.
Describe factor which contributing to occurrence of drug interaction.
Write note on use of drug in pediatrics population.
Write note on Ethical principle in clinical trials.
Write note on Meta-analysis.
3. Answer any three (10×3=30)
Explain in detail Pharmacovigilance and safety data reporting.
Write note on dosage adjustment in liver and kidney disease.
Explain in detail phases of clinical trial and types of clinical trail.
Discuss the case study of Bronchial asthma and acute myocardial infarction.