ORALLY INHALED AND NASAL DRUG PRODUCTS SUBCOMMITTEE OF

THE ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

April 26, 2000

Reports

Initial Assessment of the ITFG/IPAC Dose Content Uniformity Database by the CMC Specifications Technical Team of the ITFG/IPAC Collaboration, July 31, 2000  Cover Letter .doc .pdf

Initial Assessment of the ITFG/IPAC Aerodynamic Particle Size Distribution Database by the CMC Specifications Technical Team of the ITFG/IPAC Collaboration, August 29, 2000   Cover Letter  doc   pdf

Review of the In Vivo and In Vitro Tests in FDA's Draft Guidance on Bioavailability and bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action and Anticipated Forthcoming Guidance for Orally Inhaled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, August 30, 2000   Cover Letter   doc   pdf

Technical Paper on FDA's Bioavailability and Bioequivalence Questions Presented at 26 April 2000 OINDP Advisory Subcommittee Meeting, August 30, 2000   doc   pdf