Full Product Details
Author: Leon Shargel (Applied Biopharmaceutics, LLC, Raleigh, North Carolina, USA) ,
Isadore Kanfer (Rhodes University, Grahamstown, South Africa)
Publisher: Taylor & Francis Ltd
Imprint: CRC Press
Edition: 2nd edition
Weight: 0.734kg
ISBN: 9781032920603
ISBN 10: 1032920602
Pages: 398
Publication Date: 14 October 2024
Audience:
Professional and scholarly
,
Professional & Vocational
Format: Paperback
Publisher's Status: Active
Availability: In Print
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Reviews
""Written by experts from academia, industries, and regulatory agency, this is an update of a comprehensive review of the generic oral solid drug product development process. It presents various aspects of generic drug product development with formulation development through to post-approval changes. This edition includes a new chapter on the U.S. Pharmacopeial Convention and its role in harmonization. ... This book will be a standard reference for everyone working on or studying generic drug product development, in industry, academia, and regulatory agency."" —Rahmat M. Talukder, PhD, RPh, West Coast University School of Pharmacy, in Doody's Book Reviews ""This text would be most useful for industry and regulatory professionals, but it would also provide a good reference text for pharmacy students wanting to become familiar with the considerations of generic drug development."" —Emma McConnell, Medical Writer
"""Written by experts from academia, industries, and regulatory agency, this is an update of a comprehensive review of the generic oral solid drug product development process. It presents various aspects of generic drug product development with formulation development through to post-approval changes. This edition includes a new chapter on the U.S. Pharmacopeial Convention and its role in harmonization. ... This book will be a standard reference for everyone working on or studying generic drug product development, in industry, academia, and regulatory agency."" —Rahmat M. Talukder, PhD, RPh, West Coast University School of Pharmacy, in Doody's Book Reviews ""This text would be most useful for industry and regulatory professionals, but it would also provide a good reference text for pharmacy students wanting to become familiar with the considerations of generic drug development."" —Emma McConnell, Medical Writer"
Author Information
Leon Shargel, PhD is the manager and founder of Applied Biopharmaceutics, LLC, a pharmaceutical consulting firm. Dr. Shargel is also an Affiliate Professor, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, and Adjunct Associate Professor, School of Pharmacy, University of Maryland, Baltimore. He has wide experience in industry and academia and has more than 200 publications, including several leading textbooks in pharmaceutical education and the generic pharmaceutical industry. Dr. Shargel received his Ph.D. in pharmacology from the George Washington University, Medical Center, Washington, D.C., and his B.S. in pharmacy from the University of Maryland, Baltimore, MD. Isadore Kanfer, PhD is Professor and Emeritus Dean of Pharmacy, and former Head of Pharmacy and Dean of the Faculty (1999–2007), Rhodes University, Grahamstown, South Africa. Dr. Kanfer has been a visiting professor at the University of California-San Francisco and the University of North Carolina School of Pharmacy, Chapel Hill. He spent several years in the pharmaceutical industry in Canada and has written or contributed to several book chapters and more than 200 research publications and conference presentations. Dr. Kanfer received his B.Sc. in pharmacy and Ph.D. in pharmaceutics from Rhodes University, Grahamstown, South Africa.
