Food and Drug Administration

Advisory Committee for Pharmaceutical Science

November 28, 2001

Slides

Introduction, Helen N Winkle, FDA  [ppt] [htm]

The ACPS's Process Analytical Technology Subcommittee, Ajaz S Hussain PhD, FDA  [ppt] [htm]

Ensuring Physical Stability of Pharmaceuticals: Can/Should We Improve Our Ability to Identify and Prevent Physical Changes? Ajaz S Hussain PhD, FDA [ppt] [htm]

Predicting Physical Stability in Q1A(R), Chi-wan Chen PhD, FDA  [ppt] [htm]

Blend Uniformity - PQRI Research, Ajaz S Hussain PhD, FDA [ppt] [htm]

Background to the work of the BUWG, Garth Boehm PhD, Pfizer Inc;  BUWG Draft Recommendations, Thomas Garcia PhD Purepac Pharmaceutical Company; Data Mining: Challenging the Theory, Thomas Garcia PhD, Purepac Pharmaceutical Company [ppt] [htm]

NCSS report of the Cardiotoxicity Biomarker EWG, John Doull   [pdf] [htm] [Word]

Vascular Injury Expert Working Group, 13 Nov 01 Activity Report to NCSS, John Doull   [ppt] [htm]

NCSS Fact Finding Cardiotoxicity Expert Working Group, John Doull  [ppt] [htm]

OPEN PUBLIC HEARING

Real Time Quality Control (Batch monitoring) of Pharmaceutical production Processes, Chris Ambrozic and John Parsons, Umetrics Inc.   [ppt]  [htm]

Effusivity for Monitoring Blend Uniformity, Dr. Nancy Mathis, Blend-Tech [ppt]  [htm]

Comments on Blend Uniformity, Generic Pharmaceutical Association  [pdf] (GPhA)