PPT Slide
Commitments made at 26 April OINDP Subcommittee Meeting
- To Develop Position Statements on BA/BE Studies
- To Respond to FDA’s BA/BE Questions from 26 April OINDP Subcommittee Meeting
Prepared Two Technical Papers, Submitted to FDA on 30 August 2000
- Technical Paper on FDA’s Bioavailability and Bioequivalence Questions Presented at 26 April 2000 OINDP Advisory Subcommittee Meeting
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- Review of In Vivo and In Vitro Tests in FDA’s Draft Guidance on Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action and Anticipated Forthcoming Guidance for Orally Inhaled Drugs