Food and Drug Administration

Advisory Committee for Pharmaceutical Science

April 13, 2004


OPS Update, Helen Winkle, FDA (HTM) (PPT)

Clinical Pharmacology Subcommittee (CPSC) Report, Dr. Jürgen Venitz, MD, PhD (HTM) (PPT)

Process to Address Specifications for Delivered Dose Uniformity of Inhaled and Nasal Drug Products, Dr. Robert O'Neill, PhD (HTM) (PPT)

PAT Progress Report, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

Standards Development for PAT, Ali Afnan, FDA (HTM) (PPT)

PAT Update - Rapid Microbiology, Dr. Bryan Riley, PhD, FDA (HTM) (PPT)

Process Analytical Technology and Biotechnology Products, Dr. Keith Webber, PhD, FDA (HTM) (PPT)

Process Analytical Technologies Application for CDER-Regulated Products, Dr. Chris Joneckis, PhD, FDA (HTM) (PPT)

PET for PAT? - Process Evaluation Tools for Process Analytical Technologies in Manufacture of Biological Products, Charles Cooney, MIT, Cambridge, MA (HTM) (PPT)

The Impact of Micro-Analytical Instrumentation on PAT Applications, M. Koch, University of Washington (HTM) (PPT)

PAT and Biological Products, Tom Layloff, Management Sciences for Health (HTM) (PPT)

Questions - PAT for Products in OBP (PPT)

Open Public Hearing

PAT for Biologics - Ensuring Quality of Biologically Produced Drugs, Parrish Galliher and Elizabeth Fowler, Wcellerex (HTM) (PPT)

PAT Solution in Pharmaceutical Industry, Troy Logan, Siemens (HTM) (PPT)

Near-Infrared Spectroscopy as a Process Analytical Technology in the Biotech Industry, Robert Mattes, Foss (HTM) (PPT)