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FDA Guidance for Industry: Individual Product Bioequivalence Recommendations for Specific Products

Origin/Publisher:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072872.pdf

Document Type:
Guidance for Industry
Content:
This document describes the FDA's process for making available to the public the agency's guidance on how to design bioequivalence studies for specific drug products to support abbreviated new drug applications (ANDAs).

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