Generic drug product development
Subtitle: international regulatory requirements for bioequivalence
By: edited by Isadore Kanfer, Leon Shargel
Series: Drugs and the pharmaceutical sciences -- 201
Publisher: Informa Healthcare
Published: 2010
Place of publication: New York
Language: eng
Number of pages: 309
ISBN-13: 9780849377853
Subjects: Therapeutic Equivalency; International Cooperation; Generic Drugs; Law and legislation; Drug Design; Drug Legislation; Biological Availability; Pharmacokinetics; Standards; Generic drugs
Notes: Includes bibliographical references and index.
Table of contents: title: Australasia / C.T. Hung ... [et al.]; title: Brazil / Margareth R.C. Marques, Sílvia Storpirtis, and Márcia Martini Bueno; title: Canada / Iain J. McGilveray; title: The European Union / Roger K. Verbeeck and Joelle Warlin; title: India / Subhash C. Mandal and S. Ravisankar; title: Japan / Juichi Riku; title: South Africa / Isadore Kanfer, Roderick B. Walker, and Michael F. Skinner; title: South America and Pan American Health Organization / Silvia Susana Giarcovich and Ricardo Bolaños; title: Taiwan / Li-Heng Pao, Jo-Feng Chi, and Oliver Yoa-Pu Hu; title: Turkey / Ilker Kanzik and A. Atilla Hincal; title: United States of America / Barbara M. Davit and Dale P. Connor; title: The World Health Organization / John Gordon ... [et al.].