Guidance 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 Database 2 ► Drug Approvals and Databases > Dissolution Methods Database
"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 1-800-378-5457 (toll free) for assistance regarding submissions."
open here please:
Guidances (Drugs) > Bioequivalence Recommendations for Specific Products
.png)
No hay comentarios:
Publicar un comentario