Food and Drug Administration

Advisory Committee for Pharmaceutical Science

October 21, 2003


Welcome and Introduction, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

ACPS Manufacturing Subcommittee Update, Dr. Judy Boehlert, PhD (HTM) (PPT)

Goals of the Advisory Subcommittee, Dr. Jurgen Venitz, MD, PhD (PDF)

Does Content Uniformity: Parametric Tolerance Interval Approach, Dr. Ajaz Hussain, PhD, FDA (HTM) (PPT)

PTIT for DCU of OINDP: Approaches to Resolution of Identified Issues, Dr. Wallace Adams, PhD (HTM) (PPT)

Zero Tolerance Criteria Do Not Assure Product Quatlity, Dr. John Murphy, PhD (HTM) (PPT)

Pharmaceutical Product Quality Assurance Through CMC Drug Development Process, Darlene Rosario, IPAC-RC (HTM) (PPT)

Summary and Status of IPA-RS Proposal for Improved Control of Delivered Doses Uniformity (DDU) of Orally Inhaled and Nasal Drug Products (OINDP), Michael Golden, GlaxoSmithKline (HTM) (PPT)