Generic Drug Product Development (2^nd Ed.)
Solid Oral Dosage Forms, Second Edition
Drugs and the Pharmaceutical Sciences Series

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)
• Scale-up
• 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.

Generic Drug Product Development and Therapeutic Equivalence. Active Pharmaceutical Ingredients.
Analytical Methods Development and Methods Validation for Oral Solid Dosage Forms. Experimental Formulation Development. Scale-up, Technology Transfer, and Process Performance Qualification. Drug Stability. Quality Control and Quality Assurance. Drug Product Performance: In Vitro. ANDA Regulatory Approval Process. Bioequivalence and Drug Product Assessment: In Vivo. Statistical Considerations for Establishing Bioequivalence. Outsourcing Bioavailability and Bioequivalence Studies to Contract Research Organizations. Postapproval Changes and Postmarketing Reporting of Adverse Drug Experiences. The United States Pharmacopeia/National Formulary: Its History, Organization, and Role in Harmonization. Legal and Legislative Hurdles to Generic Drug Development, Approval, and Marketing. Index.

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.