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Generic Drug Product Development International Regulatory Requirements for Bioequivalence by Isadore Kanfer
  

Generic Drug Product Development International Regulatory Requirements for Bioequivalence

Part of the Drugs and the Pharmaceutical Sciences Series

Synopsis

Generic Drug Product Development International Regulatory Requirements for Bioequivalence by Isadore Kanfer

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

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Book Info

Publication date

15th April 2009

Author

Isadore Kanfer

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Publisher

Informa Healthcare an imprint of Taylor & Francis Inc

Format

Hardback
332 pages

Categories

Pharmaceutical technology
Pharmaceutical industries

ISBN

9780849377853

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