Orally Inhaled and Nasal Drug Products Subcommittee of the ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE July 17, 2001

Orally Inhaled and Nasal Drug Products Subcommittee of the
ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE

July 17, 2001

Slides

Bioequivalence Considerations for Locally Acting Nasal Drugs, Dale P Conner, PharmD, FDA ppt htm

The June 1999 Draft BA/BE Guidance for Nasal Aerosols and Nasal Sprays: History, Recommendations and Local Delivery Issues, Wallace P Adams PhD, FDA ppt htm

Difficulties in showing a dose-response with locally-acting nasal sprays and aerosols for allergic rhinitis, Badrul A Chowdhury MD PhD, FDA ppt htm

Clinical Study Options for locally acting nasal suspension products, Robert J Meyer MD, FDA ppt htm

Open Public Hearing

Bioequivalence Studies and Other Recommendations for Orally Inhaled and Nasal Drug Products: Work of the ITFG/IPAC-RS Collaboration, Cynthia Glynn, PhD, and Joel Sequeira, PhD ppt htm

Piyush Patel, MD, FRCP(C), Allied Chemical Research Inc. ppt htm