FDA draft guidance for bioequivalence studies.

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FDA draft guidance for bioequivalence studies.(Regulatory Update)(Food and Drug Administration)(Brief article)

Publication: Research Practitioner
Publication Date: 01-JAN-08

Format: Online
Delivery: Immediate Online Access

Article Excerpt
In the October 25, 2007, Federal Register, FDA announced the availability of draft and revised draft product-specific bioequivalence (BE) recommendations. These recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs)...

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...for generic drugs. In the May 31, 2007, Federal Register, FDA...

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