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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Bioequivalence Recommendations for Specific Products
Internet:http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072872.pdf
Origin/Publisher:FDA
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).
Status:Final
Document Type:Guidance for Industry