Generic Drug Product Development - International Regulatory Requirements for Bioequivalence

Informationen zum Autor Isadore Kanfer, Leon Shargel Klappentext 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. Zusammenfassung Generic Drug Product Development Inhaltsverzeichnis 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.

Product details

• Authors: Isadore Kanfer, Isadore Shargel Kanfer, KANFER ISADORE SHARGEL LEON, Leon Shargel, Leon Kanfer Shargel
• Assisted by: Isadore Kanfer (Editor), Kanfer Isadore (Editor), Leon Shargel (Editor)
• Publisher: Taylor & Francis Ltd.
• Languages: English
• Product format: Hardback
• Released: 15.04.2009
• EAN: 9780849377853
• ISBN: 978-0-8493-7785-3
• No. of pages: 332
• Series: Drugs and the Pharmaceutical Sciences; Drugs and the Pharmaceutical S; Drugs and the Pharmaceutical Sciences
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Non-clinical medicine; Social sciences, law, business > Business > Individual industrial sectors, branches; SCIENCE / Chemistry / General, MEDICAL / Pharmacology, environmental science, engineering & technology, Biology, life sciences, Engineering: general, Pharmaceutical technology, Manufacturing industries, Environmental science, engineering and technology, Pharmaceutical industries, Pharmaceutical chemistry and technology