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:
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.
"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
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