Exam Details
| Subject | product development and technology transfer | |
| Paper | ||
| Exam / Course | m.pharm | |
| Department | ||
| Organization | Gujarat Technological University | |
| Position | ||
| Exam Date | January, 2019 | |
| City, State | gujarat, ahmedabad |
Question Paper
Seat No.: Enrolment
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MQA104T Date: 07/01/2019
Subject Name: Product Development and Technology Transfer
Time 10:30 AM TO 01:30 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
Briefly explain current opportunities and challenges in new drug product development.
06
What is IPQC? Explain various IPQC tests for parenterals and liquid dosage form.
05
Write a note on Post marketing surveillance of product.
05
Q.2
Write a detail note on pilot plant scale up of tablets
06
Discuss selection and evaluation of pharmaceutical packaging materials.
05
Explain the documentation in technology transfer.
05
Q.3
What is Preformulation? What are objectives and principle of preformulation?
06
Give detail note on Supplemental New Drug Application (SNDA)
05
Describe optimization and production of technology transfer.
05
Q.4
Discuss SUPAC guideline in brief.
08
Give detail note on quality control test for containers and closures.
08
Q.5
Explain Bulk Active Chemical Post Approval Changes (BACPAC) in detail.
06
Discuss qualitative and quantitative models of technology transfer
05
Describe different organometalic and physical properties useful in preformulation study of pharmaceutical dosage form.
05
Q. 6
Write a note on product registration guidelines in USFDA.
08
Write a note on methods to improve solubility of drugs.
08
Q.7
Explain the different types of IND applications.
06
Write a note on New Drug Application (NDA).
05
Write a short note on Polymorphism.
05
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER EXAMINATION -WINTER 2018
Subject Code: MQA104T Date: 07/01/2019
Subject Name: Product Development and Technology Transfer
Time 10:30 AM TO 01:30 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
Briefly explain current opportunities and challenges in new drug product development.
06
What is IPQC? Explain various IPQC tests for parenterals and liquid dosage form.
05
Write a note on Post marketing surveillance of product.
05
Q.2
Write a detail note on pilot plant scale up of tablets
06
Discuss selection and evaluation of pharmaceutical packaging materials.
05
Explain the documentation in technology transfer.
05
Q.3
What is Preformulation? What are objectives and principle of preformulation?
06
Give detail note on Supplemental New Drug Application (SNDA)
05
Describe optimization and production of technology transfer.
05
Q.4
Discuss SUPAC guideline in brief.
08
Give detail note on quality control test for containers and closures.
08
Q.5
Explain Bulk Active Chemical Post Approval Changes (BACPAC) in detail.
06
Discuss qualitative and quantitative models of technology transfer
05
Describe different organometalic and physical properties useful in preformulation study of pharmaceutical dosage form.
05
Q. 6
Write a note on product registration guidelines in USFDA.
08
Write a note on methods to improve solubility of drugs.
08
Q.7
Explain the different types of IND applications.
06
Write a note on New Drug Application (NDA).
05
Write a short note on Polymorphism.
05
Other Question Papers
Subjects
- advanced medicinal chemistry
- advanced organic chemistry-i
- advanced organic chemistry-ii
- advanced pharmacology ii
- advanced pharmacology-i
- advances in drug delivery system
- advances in pharmacology
- applied pharmacotherapeutics - ii
- applied pharmacotherapeutics-i
- audits and regulatory compliance
- biological evaluations & clinical research
- cellular and molecular pharmacology
- clinical and hospital pharmacy
- clinical pharmacy practice
- clinical research and pharmacy practice
- clinical research and regulatory affairs
- clinical research regulations
- cosmetic and cosmeceuticals
- documentation and regulatory writing
- drug design and discovery
- drug regulation and regulatory authority
- experimental design and patents
- global regulatory requirements
- gmp, glp and validation
- good manufacturing and good laboratory practice
- good manufacturing practice and process validation
- good regulatory practices
- hazards and safety management
- industrial pharmacy practice
- modern analytical techniques
- modern pharmaceutical analysis
- novel drug delivery system part-i
- novel drug delivery system-ii
- pharm. management -ii
- pharmaceutical analysis ii
- pharmaceutical and cosmetic analysis
- pharmaceutical formulation and development
- pharmaceutical formulation development and biopharmceutics
- pharmaceutical manufacturing technology
- pharmaceutical production management & technology
- pharmaceutical regulatory affairs
- pharmacological and toxicological screening methods-i
- pharmacological and toxicological screening methods-ii
- pharmacometrics and methods of biological evaluation of drugs
- pharmacotherapeutics
- principles of biopharmaceutics& pharmacokinetics
- product development and technology transfer
- quality control & quality assurance
- quality control and quality assurance
- quality management system
- regulatory affairs - i
- regulatory affairs and new drug applications
- regulatory aspects of hebbal and biologicals
- research methodology
- validation and product development