Generic Drug Product Development

Generic Drug Product Development

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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.Guideline for Bioequivalence Studies of Generic Products, 1997. http://www.nihs. ... Guideline for Formulation Changes of Oral Solid Dosage Forms, 2000. formchange.PDF. 9. Ministry of Health, Labor and Welfare. ... Hauschke D, Steinijans VW, Diletti E. A distributiona€”Free procedure for the statistical analysis of bioequivalenceanbsp;...

Title:Generic Drug Product Development
Author:Isadore Kanfer, Leon Shargel
Publisher:CRC Press - 2010-03-25


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