Roll No. Total No.

of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Regulatory Affairs) (Sem.-1)
GOOD REGULATORY PRACTICES
Subject Code : MRA 101T
M.Code : 79180
Date of Examination : 21-01-23
Time: 3 Hrs. Max. Marks : 75

INSTRUCTIONS TO CANDIDATES:
1. Attempt any FIVE questions out of SIX.
2. Each question carries FIFTEEN marks.

1. a) Write a note on ECprinciples of GMP.

b) Write a note on US cGMP guidelines.

2. a) Give principles and requirements of GALP.

b) Explain software evaluation checklist in detail.

3. Discuss the USFDA GLP regulations.

4. What do youunderstand by GDP? Give principle and discuss the legal GDP requirements
in detail.

5. a) Comment on concept of quality. Explain total quality management in quality

management system.

b) Describe out of specifications concept of quality management system.

6. a) Give in detail ICH guidelines with respect to quality safety and efficacy of drug
substances and products.

b) Give types of validation with special emphasis on cleaning validation.

NOTE: Disclosure of Identityby writing Mobile No. or Marking of passing request on any
paper of Answer Sheet will lead to UMC against the Student.

1| :-79180 (S19)-2818

.D;-20) 2
 Roll No. Total No. of Pages : 01
Total No. of Questions: 06

M.Pharmacy (Regulatory Affairs) (Sem.-1)

DOCUMENTATION & REGULATORY WRITING
Subject Code : MRA102T
M.Code: 79181
Date of Examination : 23-01-23
Time : 3Hrs. Max. Marks :75

JNSTRUCTIONS TO CANDIDATES :
1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

1. Discuss in detail about Product Development Report (PDR)

2. Discuss the compilation and review of dossier in detail.

3. Discuss in detail about Print pack specifications.

4 Discuss about overview and various modules of CTD.

5. Discuss GMP compliance audit in detail.

6 Discuss in detailabout FDA inspection and enforcement.

NOTE : Disclosurepaper
of ldentity by writing Mobile No. or Marking of passing request on any
of Answer Sheet will lead to UMCagainst the Student.

1| M79181 (S35)-2830
 Roll No.LII Total No. of Pages : 01
Total No. of Questions : 06
M.Pharmacy (Regulatory Affairs) (Sem.-1)
CLINICAL RESEARCH REGULATIONS
Subject Code : MRA-103T
M.Code : 79182
Date of Examination : 25-01-23
Time: 3 Hrs. Max. Marks : 75

INSTRUCTIONS TO CANDIDATES :
1. Attempt any FIVEquestions out of SIX questions.
2. Each question carries FiFTEEN marks.
clinical trials in
1. Write about different types of Clinical studies. Describe about various phases of
detail.

Nazis trials and

2. Discuss the historical perspective of Nuremberg code, thalidomide study,
Helsinki.
Tuskegee syphilis study. Discuss about Belmont Report and Declaration of
NDA 505(b) (1)
3 Discuss the regulations to conduct drug studies as per USFDA. Discuss about
and NDA 505(b)(2) applications.
procedure of Institutional
4. Describe the composition, roles, responsibilities and ethical review
Ethics Committee.

5 Discuss about Good Clinical Practice Guidelines (ICH GCP E6)

Pharmacoepidemiological
6. Discuss about guidelines for Good Pharmacovigilance Practices and
Assessment.

NOTE: Disclosure of Identity by writing Mobile No. or Marking of passing request on any
paper of Answer Sheet will lead to UMC against the Student.
1| M-79182 (s35)-2843
 Pages: 01
Total No. of
RollNo.
Questions : 06
Total No. of (Sem.-1)
M.Pharmacy (Regulatory Affairs) COSMETICS,
LEGISLATION FOR DRUGS &
REGULATIONS& BIOLOGICALS & HERBALS, AND FOOD &
MEDICÁL DEVICE, & INTELLECTUAL PROPERTY
NUTRACEUTICALS IN INDIA
RIGHTS
Subject Code : MRA104T
M.Code : 79183
: 27-01-23
Date of Examination 75
Max. Marks :
Time: 3 Hrs.
INSTRUCTIONS TO CANDIDATES:
questions.
questions out of SIX
1.Attempt any FIVE marks.
carries FIFTEEN
2.Each question Government under DPCO?
fixed or revised by
herbals are
How the prices of biological and
1. a) as drugs under
NPPA notifies for medical devices
provisions which
b) Discuss all thequality control & price monitoring.
DPCO2013 for
permit/control and regulate the sale ofNarcotic
Government to
powers of Central
2. a) Discuss the
and Psychotropic substances.
Act.
the Education regulation prescribed in Pharmacy
b) Write
spirit from non-bonded laboratories.
requirements/steps for obtaining
3. Discuss the approvals of food and
requirements and
CDSC0 in the regulatory
4. Discuss the role of
neutraceuticals.

regulatory dossier filing.

5. Discuss the contents of bioequivalence studies.
regulatory requirements of
What are BA and BE studies? Discuss the
6. a)
research.
the ICMR guidelines for stem cell
b) Discuss

No. or Marking of passing request on any

Identityby writing Mobile against the Student.
NOTE: Disclosure of will lead to UMC
paper of Answer Sheet (S3S)-2855
1|i-79183

Dsc2o2 2
M-745781| 4. 3. 2. INSTRUCTIONS
CANDIDATES
2 1 TO Time
Hrs.:3
1. Total RollNo.
b) a) c) b) following: a)
Answerthe b) a)Autophagy a) messengers
b) Describe ELISA Second
d)Microarray
c) b) a)
techniques
Nutrigenomics Each
Attempt
Write No.
DiscussExplain Discuss Define How Describe Intrinsic M.Pharmacy
What question
of
cells notes any
are the CELLULAR
Questions
about cryopreservation.
in the and on
detail various are briefly the following FIVE
extrinsic following carries
GPCR's. isolated types
questions
JAK/STAT about (Pharmacology)
types of : FIFTEEN :
THREE)
(Any MPL-104T
Subject
Code: & 06
immunotherapeutics?
and genomics. pathways MOLECULAR
of Why out M.Code
74678 :
characterised
signalling cell it marks. of
culture. is of
SIX
used? apoptosis
(2017
questions.
pathway in
cell Discuss PHARMACOL0GY &
culture Onwards)
and
their
its Total
roles. techniques?
clinical a
No.
Max. 75 (Sem.-1)
Marks:
status. of
Pages:

02
(S31)-600 6,5 10 5 5 5 5
4 5
6 3 6
8
6. Discuss the following (Any TWO)
a) siRNA
7.5
b) Gene mapping and its applications 7.5
c) Micro RNA
7.5
d) Cell cycle and its
regulation 7.5

NOTE:Disclosure of Identity by writing Mobile No. or Making of passing request on any

page of Answer Sheet will lead to UMCagainst the Student.

2| M-74678
(S31)-600
 Total No. of Pages : 01
Roll No.
: 06
Total No. of Questions (Sem.-1)
M.Pharmacy (Pharmacology) (2017 & Onwards) SCREENING
PHARMACOLOGICAL AND TOXICOLOGICAL
METHODS-I
Subject Code : MPL-103T
M.Code: 74677 Max. Marks: 75
Time: 3Hrs.

INSTRUCTIONS TO CANDIDATES:
of SIX questions.
Attempt any FIVE questions out marks.
1. FIFTEEN
Each question carries
2.

O1. Write notes on following: 5

a) Immunoassay of digoxin 5
b) GLP
5
c) Immunomodulators

Q2. Explain in detail preclinical screening of: 7.5

a) Antidepressant agents
7.5
b) Antipyretic agents
Q3. Discuss briefly :
5
a) Elevated plus maze
5
analgesiceffect
b)One animal model for evaluation of
c) Morris water maze
screening methods for hepatoprotective
Q4. a) What are hepatoprotective agents? Discuss the 10
agents.
b)Aphrodisiacs agents Chan
05. Write notes on following :
7.5
a) Transgenic animals
7.5
b) Bioassay
alternatives to animal
Q6. What are the limitations of animal experiments? Discuss the various 15
experiments.
NOTE: Disclosure ofldentity by writing Mobile No. or Making of passing request on any
page of Answer Sheet will lead to UMC against the Student.

1| M74677 (S311-452

2020
 Roll No.
Total No. of Pages : 01
ITotal No. of Questions : 06
M. Pharmacy (Pharmacology) (2017 & 0nwards) (Sem.-1)
ADVANCED PHARMACOLOGY -1
Subject Code: MPL-102T
M.Code :74676
Time: 3Hrs. Max. Marks:75

INSTRUCTIONS TO CANDIDATES:
1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

1. a) Write a note on G-protein coupled receptors. 8

b) Add anote on cholinomimetics and their therapeutic implications. 7

2 Write notes on following:

a) ACE inhibitors.

b) Clopidogrel.
c) Streptokinase. 5

3 a) Write a note on drug therapy of Parkinsonism.

b) Discuss pathophysiology and drug therapy of mania.
4. Discusspathophysiology and drug therapy of psychosis. 15

5. Discuss critically about anti-ischemic drugs. 15

6. Write notes on following :

a) 2d Generation anti-histamines
b) Opioids 7

NOTE: Disclosure of Identity by writing Mobile No. or Making of passing request on any
pageof Answer Sheet will lead toUMC against the Student.

1|M-74676 (S31)-292
 Total No. of Pages: 01
RollNo.
Total No. of Questions : 06
M. Pharmacy (Pharmacology) (2017 & Onwards) (Sem.-1)
ADVANCED PHARMACOLOGY-I
Subject Code : MPL-102T
M.Code : 74676
Max. Marks : 75
Time : 3Hrs,

INSTRUCTIONS TO CANDIDATES:
Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

8
1. a) Write a note on G-protein coupled receptors.
implications.
b) Add a note on cholinomimetics and their therapeutic
2. Write notes on following :

a) ACE inhibitors.

b) Clopidogrel.
5
c) Streptokinase.
Parkinsonism.
3 a) Write a note on drug therapy of
of mania.
b) Discuss pathophysiology and drug therapy
15
4. Discuss pathophysiology and drug therapy of psychosis.
15
5 Discuss criticallyabout anti-ischemicdrugs.
6. Write notes on following :

a) 2d Generation anti-histamines
b) Opioids

NOTE: Disclosure of Ldentity by writing Mobile No. or Making of passing request on any
Student.
page of Answer Sheet will lead to UMCagainst the

1| M-74676 (S31)-292
 Pages:01
Total No. of

Roll No.
Questions : 06 (Sem.-1)
TotalNo. of
(Pharmacology) (2017 & Onwards)
ADVANCED PHARMACOLOGY-I
M. Pharmacy
Subject Code: MPL-1 02T
M.Code : 74676 : 75
Max. Marks

Time: 3Hrs.
CANDIDATES:
INSTRUCTIONS TO questions out of SIX questions.
Attemptany FIVE FIFTEEN marks.
1. carries
2.
Each question 8

G-protein coupled receptors.

on
1. a) Write a note therapeutic implications.
cholinomimetics and their
b) Add a note on
following:
2
Write notes on
a) ACE inhibitors.
5
b) Clopidogrel. Chan College)
c) Streptokinase. BR:
Parkinsonism.
ondrug therapy of 7
note
3 a) Write a therapyof mania.
pathophysiology and drug 15
b) Discuss therapy ofpsychosis.
pathophysiology and drug 15
4 Discuss drugs.
about anti-ischemic
5. Discuss critically
following :
6. Write noteson
anti-histamines
Generation
a) 2n
b) Opioids

Making of passing request on any

Mobile No. or Student.
Disclosure ofldentity by writingwilllead to UMC against the
NOTE : Sheet
page ofAnswer (S31)292

1| M74676
 Roll No. Total No. of Pages : 02
Total No. of Questions : 06
M.Pharmacy (Pharmacology) (2017 & Onwards) (Sem.-1)
CELLULAR & MOLECULAR PHARMACOLOGY
Subject Code : MPL-104T
M.Code: 74678
Max. Marks: 75
Time : 3 Hrs.

INSTRUCTIONS TO CANDIDATES :
1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

1. Write notes on following (Any THREE)

5
a) Nutrigenomics
5
b) Microarray techniques
c) Second messengers
GJllege, 5
d) ELISA

2 Describe the following:

en(t 5
a) Autophagy
10
b) Intrinsic and extrinsic pathways ofapoptosis
immunotherapeutics? Discuss their clinical status. 6,5
3 a) What are the types of
4
b) Describe briefly about genomics.
4 Answer the following:
6
a) How cells are isolated and characterised in
cellculture techniques?
3
used?
b) Define cryopreservation. Why it is
6
c) Discuss the various types of cell culture.
pathway and its roles. 8
a) Explain in detail JAK/STAT signalling
b) Discuss about GPCR's.

(531}-600
1| M-746/2

2o0
 6.
OTE:
d)Micro
RNA c) b)siRNA Discuss
a)
osure Cell
Gene
cycle the
mapping
following
page of and

werdentity
its and
regulation its (Any
by applications TWO)
writing
Sheet
Mobi
wil le
lead
toNo.
UMC or
Making
against
of
the
passing
Student.
request
7.5 7.5 7.5
7.5
0 on
any
RollNo. Total No. of Pages : 01
Total No. of Questions: 06
M. Pharmacy (Pharmacology) (2017 &Onwards) (Sem.-1)
ADVANCED PHARMACOLOGY-I
Subject Code : MPL-102T
M.Code:74676

Time: 3 Hrs. Max. Marks: 75

INSTRUCTIONS TO CANDIDATES:
1. Attempt any FIVE questions out of SIX questions.
2. Each question carries FIFTEEN marks.

1. a) Write a note on G-protein coupled receptors.

7
b) Add a note on cholinomimetics and their therapeutic implications.
2 Write notes on following :
a) ACE inhibitors.

b) Clopidogrel.
c) Streptokinase.
nColiege
Pha
Parkinsonism. 8
3. a) Write a note on drug therapy of

b) Discuss pathophysiology and drug therapy of mania.

15
4. Discuss pathophysiology and drug therapy of psychosis.
15
5 Discuss critically about anti-ischemic drugs.
6. Write notes on following:
8
a) 2nd Generation anti-histamines
7
b) Opioids

NOTE :Disclosure of ldentity by writing Mobile No. or Making of passing request on any
Student.
page of Answer Sheet will lead to UMCagainst the

1| M74676 (S31) 292

Roll No. Total No. of Pages : 01

Total No. of Questions:06

M.Pharmacy(Pharmacology) (2017 &Onwards) (Sem.-1)
PHARMACOLOGICAL ANDTOXICOLOGICAL SCREENING
METHODS-I
Subject Code : MPL-103T
M.Code:74677
Max. Marks: 75
Time : 3 Hrs.

INSTRUCTIONS TOCANDIDATES:
questions.
1. Attempt any FIVE questions out of SIX
marks.
2. Each question carries FIFTEEN

Q1. Write notes on following : 5

a) Immunoassay ofdigoxin 5
b) GLP 5
c) Immunomodulators
preclinical screening of:
Q2. Explain in detail 7.5
a) Antidepressant agents 7.5
b)Antipyretic agents
Q3. Discuss briefly: 5

a) Elevated plus maze 5

animal model for evaluation ofanalgesic effect

b) One
c) Morris water maze
screening methods for hepatoprotective
hepatoprotective agents? Discuss the 10
Q4. a) What are 5
agents. cye o
b) Aphrodisiacs agents
LIBRAY
:
Q5. Write notes on following
7.5
a) Transgenic animals 202O 7.5

to animal
b) Bioassay the various alternatives
limitations of animalexperiments? Discuss 15
Q0. What are the
experiments.
No. or Making of passing request on any
Identity by writing Mobile Student.
NOTE :Disclosure of ofAnswer Sheet will lead to UMCagainst the
page