Cantitate/Preț
Produs
Total produse
Vezi coșul
Generic Drug Product Development: International Regulatory Requirements for Bioequivalence de Isadore Kanfer

Generic Drug Product Development: International Regulatory Requirements for Bioequivalence

Editat de Isadore Kanfer, Leon Shargel
en Limba Engleză Paperback – 5 sep 2019
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.
Citește tot Restrânge

Toate formatele și edițiile

Toate formatele și edițiile Preț Express
Paperback (3) 31662 lei  6-8 săpt.
  CRC Press – 14 oct 2024 31662 lei  6-8 săpt.
  CRC Press – 5 sep 2019 36814 lei  6-8 săpt.
  CRC Press – 15 oct 2019 36973 lei  6-8 săpt.
Hardback (3) 95593 lei  6-8 săpt.
  CRC Press – 25 mar 2010 95593 lei  6-8 săpt.
  CRC Press – 25 mar 2010 98243 lei  6-8 săpt.
  CRC Press – 24 oct 2013 112411 lei  6-8 săpt.

Preț: 36814 lei

Preț vechi: 47719 lei
-23% Nou

Puncte Express: 552
Preț estimativ în valută:
7046€ • 7344$ • 5866£

Carte tipărită la comandă

Livrare economică 06-20 ianuarie 25

 Adaugă în coș

Wish list
Gift list
Am citit!
Adaugă în listă
Preluare comenzi: 021 569.72.76

Specificații

ISBN-13: 9780367384371
ISBN-10: 036738437X
Pagini: 332
Dimensiuni: 152 x 229 x 25 mm
Greutate: 0.45 kg
Ediția:1
Editura: CRC Press
Colecția CRC Press
Locul publicării:Boca Raton, United States

Public țintă

Academic and Professional Practice & Development

Cuprins

Introduction. Australasia. Brazil. Canada. The European Union. India. Japan. South Africa. South America and Pan American Health Organization. Taiwan. Turkey. United States of America. The World Health Organization.

Descriere

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.

Notă biografică

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 Product

Recenzii

"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