Generic Drug Product Development

ISBN 10: 0849377854 / ISBN 13: 9780849377853

Published by Taylor & Francis Group, 2010

About this Item

pp. xxi + 309 Illus. This item is printed on demand.

Seller Inventory # 7897520

Bibliographic Details

• Title: Generic Drug Product Development
• Publisher: Taylor & Francis Group
• Publication Date: 2010
• Language: English
• ISBN 10: 0849377854
• ISBN 13: 9780849377853
• Binding: Hardcover
• Condition: New

About this title

Synopsis

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.

About the Author

Isadore Kanfer, Leon Shargel