ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE (ACPS)

October 25, 2005

Slides Presented at AC meeting

 

Introduction to Meeting and OPS Update

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Helen Winkle

Director, Office of Pharmaceutical Science

(OPS), CDER, FDA

 

Establishing Drug Release or Dissolution Specifications Quality-by-Design (QbD) Approach

 

(1) Topic Introduction

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Ajaz Hussain, Ph.D.

Deputy Director, OPS, CDER, FDA

 

(2) United States Pharmacopeia (USP) Perspective

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Walter Hauck, Ph.D.

Thomas Jefferson University (representing USP)

 

(3) Generic Pharmaceutical Association (GPhA) Perspective

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John Kovaleski, Ph.D.

Teva Pharmaceuticals USA (representing GPhA)

 

(4) Pharmaceutical Research and Manufacturers

of America (PhRMA) Perspective

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Christopher Sinko, Ph.D.

Pfizer, Inc. (representing PhRMA)

 

(5) Introduction to FDA Perspective

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Moheb Nasr, Ph.D.

Director, Office of New Drug Quality
Assessment (ONDQA), OPS, CDER, FDA

 

(6) In Vivo Relevance of Drug Release Specifications

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Ajaz Hussain, Ph.D.

(7) Measuring and Managing Method Variability

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Lucinda Buhse, Ph.D.

Director, Division of Pharmaceutical Analysis,

Office of Testing and Research (OTR)

OPS, CDER, FDA

 

(8) A CMC System-based Approach for

Pharmaceutical Quality

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Vibhakar Shah, Ph.D.

Chemist, Division of New Drug Chemistry II,

ONDQA, OPS, CDER, FDA

 

(9) ICH Q8 Considerations

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Ajaz Hussain, Ph.D.

(10) Summary of Current Plan Status -- Next Steps

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Moheb Nasr, Ph.D.

(11) Topic 1 Questions

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Parametric Tolerance Interval Test for Dose Content Uniformity (PTIT)

 

(1) Update -- FDA Perspective

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Moheb Nasr, Ph.D.

PTIT Questions to the Committee

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The following presentation was given to the Advisory Committee for Pharmaceutical Science (ACPS)

on October 25, 2005. During ACPS discussion it was determined that the presentation contains data,

graphical representations, and potential conclusions that are incorrect and erroneous.  The ACPS

requested that the data and resultant graphs be reanalyzed and presented to the ACPS the following day

(October 26, 2005). This was done and a corrected presentation to the ACPS was made by Michael Golden,

representing IPAC-RS,  on October 26, 2006. The corrected presentation can be found here.
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(2) Update -- IPAC-RS Perspective

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Michael Golden

Glaxo SmithKline (representing IPAC-RS)