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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, 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
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
Process Analytical Technology • Science Board Presentation - November 16 • Process and Forming of Subcommittee • Brainstorm - Objectives of the Subcommittee • Define What Is Expected
Stability Testing and Shelf-Life • Awareness Topic • DOD Shelf-Life Program • Issues Related to Physical Stability
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
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
Nonclinical Studies Subcommittee • Update on Subcommittee Jim MacGregor, Ph.D. - NCTR • Next Steps • Future of Subcommittee
Training • No Issues To Be Discussed • Look at Ways for Committee to Interact in Future • Process • Principle Reviewers
Dermapharmacokinetics • Background • Working on Since Early 90s • Draft Guidance Issued in June 1998 • Several Joint Meetings with Derm Subcommittee • Presentations on Study Data • Three Issues for Discussion • Decision - Draft Guidance
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?