Center for
Drug Evaluation and Research
Pharmaceutical
Science Advisory Committee (ACPS)
October 06, 2006
Slides
Disclaimer
The statements
contained in this document(s) are those of the product's
sponsor, not FDA, and FDA does not necessarily agree with
the sponsor's statements. FDA has not made a final determination
about the safety or effectiveness of the product described
in this document.
Informational
Presentations
Topic
III: ACPS Highly Variable Drugs
Topic Introduction,
Lawrence Yu, Ph.D., FDA (htm)
(ppt)
Therapeutic Considerations
of Highly Variable Drugs, Leslie Benet, Ph.D., University
of California San Francisco (htm)
(ppt)
Bioequivalence of
Highly Variable Drugs, Kamal K. Midha, Ph.D., University
Saskatchewan, Canada (htm)
(ppt)
Evaluation of a
Scaling Approach for Highly Variable Drugs, Sam Haidar,
Ph.D., FDA (htm) (ppt)
FDA’s Proposal,
Barbara Davit, J.D., Ph.D, FDA (htm)
(ppt)
Awareness topic
– Risk Management for Complex Pharmaceuticals, Steven Kozlowski,
M.D., FDA (htm) (ppt)
Open
Public Hearing
Some Issues on the
Determination of Bioequivalence for Highly Variable Drugs,
Laszlo Endrenyi, Ph.D. (htm) (ppt)
Topic
IV: Critical Path Initiative (The Agency & the
Committee have decided to defer this topic to a future ACPS
meeting)
Implementation of
Definitions for Topical Dosage Forms, Lucinda Buhse, Ph.D.
(htm) (ppt)
Topic
V: Nanotechnology – Issues and Definitions
Topic Introduction/Overview,
Nakissa Sadrieh, Ph.D., FDA (htm)
(ppt)
Applicability of
Existing Regulations to the Development of a Dendrimer Nanotechnology-based
Pharmaceutical, Jeremy Paull, Ph.D, Starpharma Pty., Ltd.
(htm) (ppt)
Nanotechnology in
Emerging Medical and Consumer Products: Opportunities and
Risks, Russell M. Lebovitz, M.D., Ph.D. SUMA Partners (htm)
(ppt)
