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