Download GTU B.Tech 2020 Winter 8th Sem 2183601 Drug Delivery, Biotechnology And Validation Requirement Question Paper

Download GTU (Gujarat Technological University Ahmedabad) B.Tech/BE (Bachelor of Technology/ Bachelor of Engineering) 2020 Winter 8th Sem 2183601 Drug Delivery, Biotechnology And Validation Requirement Previous Question Paper

Seat No.: ________
Enrolment No.___________
GUJARAT TECHNOLOGICAL UNIVERSITY
BE- SEMESTER?VIII (NEW) EXAMINATION ? WINTER 2020
Subject Code:2183601 Date:19/01/2021
Subject Name:Drug Delivery, Biotechnology & Validation Requirement
Time:02:00 PM TO 04:00 PM Total Marks: 56
Instructions:
1. Attempt any FOUR questions out of EIGHT questions.

2. Make suitable assumptions wherever necessary.

3. Figures to the right indicate full marks.


MARKS
Q.1 (a) Write a note on Radiopharmcaeuticals.
03

(b) Discuss the Schedule-M guidelines for process validation
04

(c) Describe the components of aerosol system with a neat-labeled
07
diagram.
Q.2 (a) Write a note on Drug Master File.
03

(b) What are cosmetic products? Write a brief note on cosmetic products.
04

(c) Explain genetic engineering and the process involved in it.
07




Q.3 (a) Define DPCO and write a brief note on it.
03

(b) Write the components of Sustained Release Drug Delivery System
04

(c) Explain in detail Ophthalmic drug delivery system
07




Q.4 (a) Write notes on (1). Informed consent, (2). Ethics committee.
03

(b) Write the components of Transdermal Drug Delivery System (TDDS)
04

(c) Describe Liposome in detail with proper diagram.
07
Q.5 (a) Draw the basic design of fermenter. Label it properly.
03

(b) What is Preformulation. Explain the steps involved in pre formulation
04
of SRDDS (sustained release drug delivery system).

(c) Describe NDA & ANDA
07



Q.6 (a) Write a note on the aseptic operation & containment in a fermentation
03
process.

(b) What are Sustained release & Controlled release dosage forms. Write
04
the differences between these two dosage forms.

(c) What is Schedule Y? What are the requirements & guidelines needed
07
for schedule Y
Q.7 (a) Write a note on recombinant DNA technology
03

(b) Define aerosols and explain its evaluation tests in detail
04

(c) Describe: Sterilization of fermenter & sterilization of air supply in a
07
fermenter with suitable diagrams



Q.8 (a) Write a note on restriction enzyme.
03
(b) What are emulsions? Explain the role of emulsifying agent.
04
(c) Describe solid state fermentation. Compare solid state fermentation
07
(SSF) & submerged liquid fermentation (SLF)
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