Orally Inhaled and Nasal Drug Products Subcommittee of the
Advisory Committee for Pharmaceutical Science
July 17, 2001
11:30 A.M. OPEN PUBLIC SPEAKERS in order of speaking
Inhalation Technology Focus Group (ITFG) of the American Association of Pharmaceutical Scientists and the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS) Ė provided a written statement for the records (handout on table)
"Review of CMC OINDP Issues Addressed by ITFG/IPAC-RS Collaboration"
Cynthia L. Flynn, Ph.D.
1660 N Hilltop Road
Spring House, PA 19478
"Review of BA/BE Teamís Work; Teamís Comments on Issue of Dose Response "
Joel Sequeira, Ph.D.
Senior Associate Director
Schering Plough Research Institute
2000 Galloping Hill Road
Kenilworth, NJ 07033
"Environmental Exposure Chamber, and the Design of a Pilot Study to Determine Dose Response and Response Variability with Topical Nasal Steroids"
Piyush Patel, M.D., FRCP(C)
Medical Director & CEO
Allied Clinical Research Inc.
4520 Dixie Road
Mississauga, Ontario L4W 1N2