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A Concise Textbook of Drug Regulatory Affairs

A Concise Textbook of Drug Regulatory Affairs

A Concise Textbook of Drug Regulatory Affairs

N Udupa,Krishnamurthy Bhat

Availability: In stock

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ISBN 978-93-82460-22-0
Type Printed
Pages 160
Category Text Books, All Books, Printed Book
Publisher MUP Book

This book has 12 chapters covering nearly all the areas of Drug Regulatory Affairs. Various aspects of Drug Regulatory Affairs such as new drug approval procedure, pharmacovigilance, product recall, evolution of drug regulations in the United States of America (USA) and process of drug approval in the USA and European Union, bioequivalence regulations, electronic Common Technical Documents (eCTD), environmental regulations, orphan drugs pharmaceutical pricing and control policy, Pharmacovigilance system in India and the USA, Product Recall, regulations of pharmaceutical drug promotion and Pharmacy Practice regulations are covered in this book. As a whole, the book is a comprehensive reference book on regulatory affairs and will be very useful for the practicing professionals and students alike.


Manipal Universal Press (MUP)
Behind Post Office, Manipal - 576 104
Udupi, Karnataka, India
T: +91-820-2922516, 2922954