Bioequivalence Recommendations for Specific ProductsGuidance for Industry: Bioequivalence Recommendations for Specific Products (PDF - 81KB)1 (Issued June 2010)
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm072872.pdf
Dissolutions Methods Database2
http://www.fda.gov/Drugs/InformationOnDrugs/ucm135742.htm
"Please submit comments for any of the guidances posted in the Bioequivalence Recommendations for Specific Products website to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. For electronic comments refer to the website http://www.regulations.gov3/ OR you can mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov HelpDesk at 1-877-378-5457 (toll free) for assistance regarding submissions."
Guidances (Drugs) > Bioequivalence Recommendations for Specific Products
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