
Pharmaceutical Regulatory Science Syllabus, Notes, MCQ, books, PDF
Unit I New Drug Discovery and development
Unit II Regulatory Approval Process
Unit III Registration of Indian drug products in the overseas market
Unit IV Clinical trials
Unit V Regulatory Concepts
Unit 5 MCQ Regulatory Concepts MCQ
Pharmaceutical Regulatory Science MCQ
Recommended books (Latest edition):
- Drug Regulatory Affairs by Sachin Itkar, Dr. N.S. Vyawahare, Nirali Prakashan.
- The Pharmaceutical Regulatory Process, Second Edition Edited by Ira R. Berry and Robert P. Martin, Drugs and the Pharmaceutical Sciences,Vol. 185. Informa Health care Publishers.
- New Drug Approval Process: Accelerating Global Registrations By Richard A Guarino, MD, 5th edition, Drugs and the Pharmaceutical Sciences,Vol. 190.
- Guidebook for drug regulatory submissions / SandyWeinberg. By John Wiley & Sons. Inc.
- FDA Regulatory Affairs: a guide for prescription drugs, medical devices, and biologics /edited by Douglas J. Pisano, David Mantus.
- Generic Drug Product Development, Solid Oral Dosage forms, Leon Shargel and Isader Kaufer, Marcel Dekker series, Vol.143
- Clinical Trials and Human Research: A Practical Guide to Regulatory Compliance By Fay A. Rozovsky and Rodney K. Adams
- Principles and Practices of Clinical Research, Second Edition Edited by John I. Gallin and Frederick P. Ognibene
- Drugs: From Discovery to Approval, Second Edition By Rick Ng
Final Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise
Suggested readings
Recommended readings: