Bioequivalence; Its History, Practice, and Future
Journal Title: The AAPS Journal - Year 2009, Vol 11, Issue 4
Abstract
In the United States, the FDA approves and grants marketing authorization of generic drugs by applying the regulatory requirements provided in the Code of Federal Regulations (CFR). The following table provides some of the relevant sections in the CFR important from BA/BE standpoint (Table ​(TableI I ).
Authors and Affiliations
Kamal K. Midha, Gordon McKay
Keywords
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