Drug Regulatory Affairs

Drug Regulatory Affairs

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Product Specifications

Publisher Nirali Prakashan All B. Pharmacy books by Nirali Prakashan
ISBN 9789380064680
Author: Dr. N. S. Vyawahare, Mr. Sachin C. Itkar
Number of Pages 326
Edition Fourth Edition
Available in all digital devices
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Drug Regulatory Affairs by Dr. N. S. Vyawahare, Mr. Sachin C. Itkar
Book Summary:

Pharmaceutical Industry is one of the most intense “Knowledge Driven” industry, which is continually in a state of dynamic transition. This industry will always remain a growing industry and will thrive in the future due to demands of a globally enlarging and aging population with diverse disease profiles and changing life styles. The process of “New Drug Discovery & Development” is very complex, expensive, time consuming that require on an average 12 -15 years at a cost of over US$ 1BN to produce a new drug to the market. This entire activity is carried out under strict regulatory supervision. The regulatory Authorities of different countries are actively involved in monitoring and controlling Quality, Safety and Efficacy of drugs developed as well as manufactured by Pharmaceutical sector.

Audience of the Book :
This book Useful for B. Pharma and M. Pharma student.
Table of Contents:

1. Regulatory Affair and its Importance

2. Drug Discovery and Development

3. Regulatory Strategy

4. Investigational New Drug Application (IND)

5. New Drug Application (NDA)

6. Abbreviated New Drug Application (ANDA)

7. Drug Master File (DMF)

8. Orphan Drug

9. Biological Licensing Application (BLA)

10. Registration of Drug Products in Overseas Markets – Pharmaceutical Export

11. Regulatory Authorities and Agencies

12. Overview of Drug and Cosmetic Act

13. Regulatory Guidelines

14. Useful Information