Gujarat Technological University 2010 M.Pharm Biological Evaluations and Clinical Research - Question Paper

Q.1 (a) define the LAL test for pyrogens. 06
(b) define depyrogenation techniques in detail. 05
(c) explain acute toxicity. 05
Q.2 (a) define principle of GCP as per ICH guideline. 06
(b) define investigator brochure. 05
(c) Explain: Investigator, Sponsor, Informed consent, protocol and serious
adverse effects.
05
Q.3 (a) What is biological standardization? provide its importance. define
parallel–line model of bioassay.
06
(b) define matching and graphical method of bioassay. 05
(c) What is radio immunoassay? define its principle. provide its
advantages and limitations.
05
Q.4 (a) Explain: Pharmacokinetic, bioavailability, bioequivalence and steady
state.
06
(b) define advantages of urinary excretion studies. discuss also the
criteria for obtaining valid urinary excretion data.
05
(c) define briefly design and conduct of bioequivalence.
05
Q.5 (a) What is toxicity study? define briefly the parameters for measuring
toxic effect.
06
(b) define toxicity testing of plastic container for ophthalmic
preparations.
05
(c) Why is test for bacteriostasis and fungistasis carried out before sterility
testing. define method A of sterility testing.
05
Q. six (a) define 1 compartment open model- intravenous infusion. 06
(b) Explain, classify and provide uses of pharmacokinetic models. 05
(c) define microbial limit tests with its applications. 05
Q.7 Write a short notes on the followings:
a. Bio-waver
b. Rabbit pyrogen test
c. Extraction of drugs from biological matrix.

Earning:   Approval pending.