Roll No.: I2- Enrolment No.

: 17 22 €-D~rto 12-

L. M. College of Pharmacy, Ahmedabad

First Sessional Examination

Pharm.D -V

Subject Code: 858801 Date: 26/08/2021

Subject Name: Clinical Research

Time: 12.00 to 1.30 p.m Total Marks:

Instructions:

A. Attempt any TWO from THREE questions.

B. Make suitable ;issumptions wherever necessary.
C. Figures at right indicate full marks.
-
Q.1

.,
V

C
Describe the important characteristics a11d possible outcomes of Phase-U \
Clinical Trials
Briefly describe the requirements for filing an IND aoolication
Differentiate between Cohort Study and Cross-Sectional Study
3
2
s

Q.2 v( Write a detai led note on Post Marketing Surveillance 5

Draw a sketch diagram that describes all the steps of Drug Discovery and 3
Development
~ Comment on: "Phase 1 is the gateway between scientific research and clinical 2
practice."
Q.3 A What is Internal Validity of an experiment. How does it impact the study design 5
and the outcome of the study
B Distinguish between following terms: "Serious Adverse Event". "Seri ous 3
Adverse Drug Reaction" and "Suspected Unexpected Serious Adverse
Reaction"
C Enlist the toxicological studies to be conducted for new drug 2

Page 2 of 2
Roll No.: I~ Enrolment No.: I] '2 2 eo~~'(O 12-
L. M. College of Pharmacy, Ahmedabad
First Sessional Examination Pharm. D. (Fifth Year)
Subject Code: 858802 Date: 27/08/2021
Subject Name: Pharrnacocpidemiology and Pharmacoeconomics
Time: 12.00 to 1.30 pm Total Marks: 30
Instructions:
A. Question No. 1 is compulsory.
8. Make suitable assumptions wherever necessary.
C. Figures to the right indicate full marks.

Q. 2~ ) What is Pharmacoecono mic? Write in detail about of cost of illness

analysis along with suitable example and its application. 5
Jl31 Ex plain in brief about Prevalence- vs. incidence-based approaches 111

cost of illne-,c; analysis. 3

\)Q'r' Write the importance of Pharmacoeconomics. 2

Q. 3 (A) Explain Tools of measurement.% ~\A.O..>U'('l()_U) ~,al.LM.L~~ OJ.Ad

(B) Write a note on history of Pharmacoepidemiolog). e_,~§-. t ·
(C) In a survey of I, 150 women who gave bi1ih in Maine in 2000, a total of
468 reported taking a multi, itamin at least 4 times a \\'eek during the
month before becoming pregnant. Calculate the prevalence o f frequent
mulli\itamin use in this group. 2

Q. 4 t£kf Describe Drug Use Measures. 5

cL0f Consider an outbreak of shigellosis in whi ch 18 persons in 18 different
households all became ill. If the population of the commun it) was 1.000,
then the overall attack rate was 18 / 1.000 x I00% = 1.8%. One
incubation period later, 17 persons in the same households as these
··primary" cases developed shigellosis. If the 18 households included 86
persons, calculate the secondary attack rate. 3
~ Enlist Basic Measurements in Epidemiology. 2

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Roll No.: -\1- Enrolment No.: \7'2 2 ~O 8%~0 l'l.
----
L. M. College of Pharmacy, Ahmedabad
First Sessional Examination Pharm. D. (Fifth Year)
Date: 28/08/2021
Subject Code: 858803
Subject Name: Clinical Pharmacokinetics
Time:12:00PM to 1:30PM Total Marks: 30
Instructions:
A. Question No. l is compulsory.
B. Make suitable assumptions wherever necessary.
C. Figures to the right indicate full marks.

Q. 2 J#J
Explain absorption and distribution in details with the exam
ple 5
3
~ Describe Loading dose with example
2
JJ2'5 What is clinical pharmacokinetic

5
Q.3 (A) Explain Metabolism and elimination in details
? 3
(B) What is maintenance dose and explain with example
e
(C) Mention the parameter wi II be measLLre durin g multiple dosag
regimen? 2

5
Q.4 Write note on JV to Oral therapy in details
J)0
clinical Condition 3
~ Describe limitation ofJV to Oral therapy with

~ What is first and zero order pharmacokinetic

2

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