ADVISORY COMMITTEE FOR PHARMACEUTICAL SCIENCE
(ACPS)
Slides Presented at AC meeting
|
Introduction to Meeting and OPS Update |
Helen Winkle Director, Office of Pharmaceutical Science (OPS), CDER, FDA |
|
Establishing Drug Release or
Dissolution Specifications – Quality-by-Design (QbD) Approach |
|
|
(1) Topic
Introduction |
Ajaz Hussain, Ph.D. Deputy Director,
OPS, CDER, FDA |
|
(2) |
Walter Hauck, Ph.D.
|
|
(3) Generic
Pharmaceutical Association (GPhA) Perspective |
John Kovaleski,
Ph.D. Teva
Pharmaceuticals USA (representing GPhA) |
|
(4) Pharmaceutical Research and Manufacturers of |
Christopher Sinko,
Ph.D. Pfizer, Inc. (representing
PhRMA) |
|
(5) Introduction to FDA Perspective |
Moheb Nasr, Ph.D. Director, Office of
New Drug Quality |
|
(6) In Vivo Relevance of Drug Release
Specifications |
Ajaz Hussain, Ph.D. |
|
(7) Measuring and Managing Method
Variability |
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 |
Vibhakar Shah, Ph.D. Chemist, Division of New Drug Chemistry II, ONDQA, OPS, CDER, FDA |
|
(9) ICH Q8 Considerations |
Ajaz Hussain, Ph.D. |
|
(10) Summary of Current Plan
Status -- Next Steps |
Moheb Nasr, Ph.D. |
|
(11) Topic 1 Questions |
|
|
Parametric Tolerance Interval Test for Dose Content Uniformity
(PTIT) |
|
|
(1) Update -- FDA Perspective |
Moheb Nasr, Ph.D. |
|
PTIT Questions to the Committee |
|
|
The following
presentation was given to the Advisory Committee for Pharmaceutical Science
(ACPS) on 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 ( representing IPAC-RS,
on |
|
|
(2) Update -- IPAC-RS Perspective |
Michael Golden Glaxo SmithKline (representing IPAC-RS) |