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Food and Drug Administration

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)

FDAs 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)


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