Generic Drug Product Development: International Regulatory Requirements for Bioequivalence

by Kanfer; Isadore

• ISBN13: 9780849377853
• ISBN10: 0849377854
• Edition: 1st
• Format: Hardcover
• Copyright: 2010-03-25
• Publisher: CRC Press

Summary

Due to a worldwide need for lower cost drug therapy, use of generic and multi-source drug products have been increasing. To meet international patent and trade agreements, the development and sale of these products must conform to national and international laws, and generic products must prove that they are of the same quality and are therapeutically equivalent to the brand name alternative. However, many countries have limited resources to inspect and verify the quality of all drug products for sale in their country.  This title discusses the worldwide legislative and regulatory requirements for the registration of generic and multi-source drug products.

Author Biography

Isadore Kanfer is Professor and Emeritus Dean of Pharmacy, and former Head of Pharmacy and Dean of the faculty (1999-2007), Rhode's-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. 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 lssues, 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.

Table of Contents

Introduction. Worldwide Market for Generic Drugs. Patents and Intellectual Property. International Conference on Harmonization. International Inspections, PIC. Pharmacopoeia Harmonization and International Standards. WHO-Essential Drug List and Multi-source Drug Products. Registration in US. Registration in EU. Registration in Japan. Registration in Canada. Registration in Australia. Registration in South America (Brazil). Registration in South Africa. Registration in India. Registration in Turkey. Registration in Thailand