Orally Inhaled and Nasal Drug Products Subcommittee of the

Advisory Committee for Pharmaceutical Science

OPEN SPEAKERS

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.

RWJ-PRI

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

Canada