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Generic Drug Product Development International Regulatory Requirements For Bioequivalence Isadore Kanfer Ed

  • SKU: BELL-4421682
Generic Drug Product Development International Regulatory Requirements For Bioequivalence Isadore Kanfer Ed
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Generic Drug Product Development International Regulatory Requirements For Bioequivalence Isadore Kanfer Ed instant download after payment.

Publisher: Informa Healthcare
File Extension: PDF
File size: 3.43 MB
Pages: 330
Author: Isadore Kanfer (ed.), Leon Shargel (ed.)
ISBN: 9780849377853, 0849377854
Language: English
Year: 2010

Product desciption

Generic Drug Product Development International Regulatory Requirements For Bioequivalence Isadore Kanfer Ed by Isadore Kanfer (ed.), Leon Shargel (ed.) 9780849377853, 0849377854 instant download after payment.

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.

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