FDA Guidance for Industry: Individual Product Bioequivalence Recommendations for Specific Products
Title:
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).