Download GTU BE/B.Tech 2019 Summer 8th Sem New 2183601 Drug Delivery Biotechnology And Validation Requirement Question Paper

Download GTU (Gujarat Technological University) BE/BTech (Bachelor of Engineering / Bachelor of Technology) 2019 Summer 8th Sem New 2183601 Drug Delivery Biotechnology And Validation Requirement Previous Question Paper

1
Seat No.: ________ Enrolment No.___________

GUJARAT TECHNOLOGICAL UNIVERSITY

BE - SEMESTER ?VIII(NEW) EXAMINATION ? SUMMER 2019
Subject Code:2183601 Date:09/05/2019

Subject Name:Drug Delivery, Biotechnology & Validation Requirement

Time:10:30 AM TO 01:00 PM Total Marks: 70

Instructions:

1. Attempt all questions.

2. Make suitable assumptions wherever necessary.

3. Figures to the right indicate full marks.
*********

MARKS

Q.1 (a) Write a note on ?Liposome? 03
(b) Discuss about Pre-formulation & the steps involved in the pre-
formulation of sustained release drug delivery system.
04
(c) Discuss about the role of agitators in Fermentation and list out the
different types of agitators used in fermentation. Describe any two in
detail.
07
Q.2 (a) Write a note on radiopharmaceuticals 03
(b) What are the roles of restriction enzyme in recombinant DNA
technology. Write a brief note on it.
04
(c) Explain genetic engineering and the process involved in it. 07
OR
(c) Describe the components of aerosol system with a neat-labeled
diagram
07
Q.3 (a) Discuss about New Drug Application and the types of data involved 03
(b) Write in detail about Schedule-M guidelines for Process validation 04
(c) Differentiate between solid state fermentation (SSF) & submerged
liquid fermentation (SLF).
07
OR
Q.3 (a) Write a note on ?Drug Master File? 03
(b) Discuss Transmucosal drug delivery system in detail. 04
(c) What are the major components of Fermentation process? Discuss
about them.
07
Q.4 (a) Define aerosols and explain its evaluation tests in detail 03
(b) Describe the classifications & the components of the transdermal drug
delivery system (TDDS).
04
(c) Explain in detail ?Ophthalmic drug delivery system? 07
OR
Q.4 (a) What are emulsions? Explain the role of emulsifying agent 03
(b) Write a note on cosmetic products 04
(c) Discuss sustained and controlled release dosage forms. Describe in
detail about the material used for the sustained release drug delivery.
07
Q.5 (a) Write a note on how sterilization is effected in fermenter. 03
(b) What is ?DPCO?. Write a detailed note on it. 04
(c) Describe Immobilized enzyme in detail. 07
OR

Q.5 (a) Draw the basic design of fermenter. Label it properly. 03
(b) Write notes on (1). Informed consent, (2). Ethics committee. 04
(c) Describe NDA & ANDA in detail. 07
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