Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MPL202T Date: 17/11/2018
Subject Name: Pharmacological and Toxicological Screening Methods-II
Time :02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1

Define toxicokinetics. Explain the toxicokinetic evaluation in preclinical studies.
06

Define LD50. Write a note on determination and importance of LD50.
05

Write a note on HERG assay and its importance.
05
Q.2

Explain the study design, conduct, and evaluation of teratogenicity studies.
06

Write a note about the different regulatory guidelines for conducting toxicity studies.
05

Discuss in vitro and in vivo studies for genotoxicity in detail.
05
Q.3

Write a note on sub-acute oral toxicity studies as per OECD guidelines.
06

Explain the principles of GLP. Write its importance in drug development.
05

Describe the format of test report according to OECD guidelines.
05
Q.4

Explain the regulatory requirement of ICH for the new drug safety assessment.
06

How topical formulations are tested pre-clinically using in-vivo and in-vitro
methods?
05

Explain acute inhalation toxicity studies as per OECD guidelines.
05
Q.5

Discuss the study design and importance of male reproductive toxicity testing.
06

Explain the study design, conduct, and evaluation of ocular toxicity study.
05

Write a note on repeated dose study.
05
Q. 6

Write brief outline about Tier I and Tier II safety pharmacology studies.
06

Explain the types of IND. Write the details of IND application form.
05

Write a note on carcinogenicity testing studies.
05
Q.7

Explain the followings:
General toxicology
Regulatory toxicology
Mechanistic toxicology
Descriptive toxicology
06

Describe the alternative methods of animal toxicity studies.
05

Write a note on saturation kinetics.
05