Generic Drug Product Development ─ Specialty Dosage Forms

Generic Drug Product Development: Specialty Dosage Forms explores the issues in providing evidence of pharmaceutical equivalence and bioequivalence for specialty drug products. In addition, the book provides various scientific approaches and regulatory requirements for manufacturers to demonstrate the therapeutic equivalence of generic specialty drug products to brand name alternatives. This book discusses measurement of drug product quality and performance, as well as the regulatory and scientific requirements of topical, nasal and inhalation, generic biologics, and other drug products.

The book will be of interest of specialists and researchers in pharmaceutical drug development, regulation, manufacturing, and others in the pharmaceutical sciences.

LEON SHARGEL is Manager, Applied Biopharmaceutics, LLC, Raleigh, North Carolina, USA. Dr. Shargel is also Affiliate Associate Professor, School of Pharmacy, Virginia Commonwealth University, Richmond, Virginia, and Adjunct Associate Professor, School of Pharmacy, University of Maryland, Baltimore, Maryland, USA. He received his B.S. in Pharmacy from the University of Maryland, Baltimore, MD and his Ph.D. in Pharmacology from the George Washington University Medical Center, Washington D.C., USA. Dr. Shargel is a registered pharmacist and has written over 150 papers, chapters and several major textbooks within the subject of pharmaceutical science. He is also co-editor of Informa Healthcare’s Generic Drug Product Development: Bioequivalence Issues, Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, and Generic Drug Product Development: Specialty Drug Products. Dr. Shargel currently serves on the USP Biopharmaceutics Expert Committee and is actively involved in teaching and consulting activities.

ISADORE KANFER is Professor and Emeritus Dean of Pharmacy, and former Head of Pharmacy and Dean of the Faculty (1999-2007), Rhodes University, Grahamstown, South Africa. He has been a visiting professor at the University of California, San Francisco, California, and the University of North Carolina School of Pharmacy, Chapel Hill, North Carolina, USA. Dr. Kanfer also spent several years in the pharmaceutical industry in Canada. He received his BSc(Pharmacy) degree and Ph.D. in Pharmaceutics from Rhodes University, Grahamstown, South Africa. Having written or contributed to several book chapters and more than 200 research publications and conference presentations, Dr. Kanfer is Co-Editor of Informa Healthcare’s Generic Drug Product Development: Bioequivalence Issues, Generic Drug Product Development: International Regulatory Requirements for Bioequivalence, and Generic Drug Product Development: Specialty Drug Products. He was awarded Honorary Life membership of the South African Academy of Pharmaceutical Sciences and is Associate Editor of the Journal of Pharmacy & Pharmaceutical Sciences and a member of the editorial board of the Journal of Pharmaceutical & Biomedical Analysis. Dr. Kanfer was the recipient of the 2007 Rhodes University Vice Chancellor’s Distinguished Senior Research Award.