In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.
Generic Drug Product Development: Solid Oral Dosage Forms, Second Edition presents in-depth discussions from more than 30 noted specialists describing the development of generic drug products—from the raw materials to the development of a therapeutic-equivalent drug product to regulatory approval.
Major topics discussed include:
- Active pharmaceutical ingredients
- Experimental formulation development, including a new section on Quality by Design (QbD)
- Commercial product formulation
- Quality control and bioequivalence
- Drug product performance
- ANDA regulatory process
- Post-approval changes
- Post-marketing surveillance
- Legislative and patent challenges
This second edition also contains a new chapter on the relationship between the FDA and the United States Pharmacopeia and in Chapter 4, using specific examples, the application of Quality by Design (QbD) during formulation development is examined.The book is a thorough guide to the development of solid oral generic dosage formulations. This textbook is ideal for the pharmaceutical industry, graduate programs in pharmaceutical sciences, and health professionals working in the area of generic drug development.
Table of Contents
Generic Drug Product Development and Therapeutic Equivalence; Leon Shargel and Isadore Kanfer
Active Pharmaceutical Ingredients; Edward M. Cohen and Steven Sutherland
Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms; Quanyin Gao and Dilip R. Sanvordeker
Experimental Formulation Development; Isadore Kanfer, Roderick B. Walker, Raimar Löbenberg, and Nádia Araci Bou-Chacra
Scale-up, Technology Transfer, and Process Performance Qualification; Salah U. Ahmed, Ashok Katdare, Venkatesh Naini, and Dilip Wadgaonkar
Drug Stability; Pranab K. Bhattacharyya
Quality Control and Quality Assurance; Loren Gelber
Drug Product Performance: In Vitro; Pradeep M. Sathe, John Duan, and Lawrence X. Yu
ANDA Regulatory Approval Process; Timothy W. Ames and Aaron Sigler
Bioequivalence and Drug Product Assessment: In Vivo; Barbara M. Davit and Dale P. Conner
Statistical Considerations for Establishing Bioequivalence; Charles Bon and Sanford Bolton
Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations; Patrick K. Noonan
Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences; Lorien Armour and Leon Shargel
The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization; William Brown and Margareth R. C. Marques
Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing; Arthur T. Tsien
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.
"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