Brand New Paperback International Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery. Bookseller Inventory #
Synopsis: The assessment of bioequivalence is an important process whereby the bioavailability of a generic drug product is compared with its brand-name counterpart. Generic pharmaceutical products must be approved as therapeutic equivalents to the brand name alternative in order to be interchangeable. The demonstration of bioequivalence is an important component of therapeutic equivalence. Bioequivalence studies are very expensive, time consuming and always have the possibility of failure. The objective of this textbook is to describe some of those specific bioequivalence issues which need to be considered for the design and conduct of bioequivalence studies. By exploring scientific, legal, and international regulatory challenges, Generic Drug Development, discusses the use of alternative approaches to the measurement of plasma drug concentrations for the demonstration of bioequivalence, and covers bioequivalence procedures for drug products that are not easily assessed - based upon the physical and chemical properties of the active drug and the nature of the drug product.
About the Author:
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.
Title: Generic Drug Product Development: ...
Book Condition: New
Book Description Taylor & Francis Group. Book Condition: New. pp. 288. Bookseller Inventory # 7371429
Book Description Book Condition: New. New. Original edition. Perfect condition. Customer satisfaction our priority. Bookseller Inventory # ABE-FEB-68890
Book Description Book Condition: Brand New. New. SoftCover Original edition. Customer Satisfaction guaranteed!!. Bookseller Inventory # SHUB68890
Book Description Book Condition: Brand New. New, SoftCover Original edition. Excellent Customer Service. Bookseller Inventory # ABEUSA-68890
Book Description Book Condition: Brand New. Brand New Paperback International Edition, Perfect Condition. Printed in English. Excellent Quality, Service and customer satisfaction guaranteed!. Bookseller Inventory # AIND-5192
Book Description Book Condition: New. Brand New Paperback International Edition.We Ship to PO BOX Address also. EXPEDITED shipping option also available for faster delivery. Bookseller Inventory # AUSBNEW-5192
Book Description 2008. Book Condition: Brand New. .. Black & White or color International Edition. ISBN and front cover may be different, but contents are same as the US edition. Book printed in English. Territorial restrictions may be printed on the book. GET IT FAST within 3-5 business days by DHL/FedEx/Aramex and tracking number will be uploaded into your order page within 24-48 hours. Kindly provide day time phone number in order to ensure smooth delivery. No shipping to PO BOX, APO, FPO addresses. 100% Customer satisfaction guaranteed!. . Bookseller Inventory # UBS10634
Book Description Taylor & Francis, 2008. N.A. Book Condition: New. International Edition. International Edition. Bookseller Inventory # 417079
Book Description INFRMA-HC, 2007. Hardcover. Book Condition: Used: Good. Bookseller Inventory # SONG0849377846
Book Description CRC Press, 2007. Hardcover. Book Condition: Very Good. Great condition with minimal wear, aging, or shelf wear. Bookseller Inventory # P020849377846