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Advisory Committee for Pharmaceutical Science Rockville, MD November 28 and 29, 2001

Advisory Committee for Pharmaceutical Science Rockville, MD November 28 and 29, 2001. Introduction. Helen N. Winkle Acting Director Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration. Office of Pharmaceutical Science.

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Advisory Committee for Pharmaceutical Science Rockville, MD November 28 and 29, 2001

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  1. Advisory Committee for Pharmaceutical Science Rockville, MDNovember 28 and 29, 2001 Introduction Helen N. Winkle Acting Director Office of Pharmaceutical Science Center for Drug Evaluation and Research Food and Drug Administration

  2. Office of Pharmaceutical Science

  3. ACPS - Organization Advisory Committee for Pharmaceutical Science Orally Inhaled Nasal Drug Products Subcommittee Nonclinical Studies Subcommittee Clin/Pharm Subcommittee Emerging Technologies Subcommittee Drug Safety and Risk Management Subcommittee

  4. Process Analytical Technology • Science Board Presentation - November 16 • Process and Forming of Subcommittee • Brainstorm - Objectives of the Subcommittee • Define What Is Expected

  5. Stability Testing and Shelf-Life • Awareness Topic • DOD Shelf-Life Program • Issues Related to Physical Stability

  6. AAPS Board of Directors Exec. Sec. FDA Steering Committee GPIA NAPM CHPA NPA PDA PhRMA Technical Committees Working Groups New Members IPEC ISPE USP Product Quality Research Institute (PQRI) - Organization CHPA GPhA PDA PhRMA New Members IPEC ISPE USP

  7. Blend Uniformity and Potential Impact of PQRI Research • Discuss Proposal and Emerging Recommendations Tom Garcia, Ph.D. - Chair of PQRI Working Group • Input from Committee • Next Steps

  8. Nonclinical Studies Subcommittee • Update on Subcommittee Jim MacGregor, Ph.D. - NCTR • Next Steps • Future of Subcommittee

  9. Training • No Issues To Be Discussed • Look at Ways for Committee to Interact in Future • Process • Principle Reviewers

  10. Dermapharmacokinetics • Background • Working on Since Early 90s • Draft Guidance Issued in June 1998 • Several Joint Meetings with Derm Subcommittee • Presentations on Study Data • Three Issues for Discussion • Decision - Draft Guidance

  11. Individual Bioequivalence (IBE) • Step Back and Reevaluate Use of IBE • Replicate Design Studies • Opinions from Scientific Community - Les Benet, Ph.D. • Four Discussion Topics • Where to From Here?

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