Generic Drug Product Development (eBook, PDF)

International Regulatory Requirements for Bioequivalence

Redaktion: Kanfer, Isadore; Shargel, Leon

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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 therapeutica

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