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Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD

Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD. Introductory Remarks. Helen N. Winkle Acting Director Office of Pharmaceutical Science Center for Drug Evaluation and Research. Accomplishments of Committee in the Last Three Years.

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Advisory Committee for Pharmaceutical Science October 21, 2002 Rockville, MD

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  1. Advisory Committee forPharmaceutical ScienceOctober 21, 2002Rockville, MD Introductory Remarks Helen N. Winkle Acting Director Office of Pharmaceutical Science Center for Drug Evaluation and Research

  2. Accomplishments of Committee in the Last Three Years • Provided input into food effect guidance • Provided input on Biopharmaceutical Classification System (BCS) • Helped in establishing Process Analytical Technologies (PAT) subcommittee

  3. Accomplishments (cont.) • Discussed dermatopharmacokinetics (DPK) and helped in making decision to withdraw draft guidance and focus on more general bioequivalence methodology for topicals • Discussed PQRI project on blend uniformity assisting OPS in determining acceptability of recommendations

  4. Accomplishments (cont.) • Debated individual bioequivalence and replicate design and provided OPS with feedback that served as background for making changes to General BA/BE Guidance • Orally Inhaled and Nasal Drug Products (OINDP) - recommendations for BA/BE and chemistry guidances

  5. Accomplishments (cont.) • Participated in awareness sessions on the following topics: • lactation • polymorphism • liposomes • risk based CMC review

  6. Current Subcommittees • PAT • OINDP • NCSS

  7. Vision for SubcommitteeStructure of ACPS ACPS Manu- facturing Clinical Pharm Pharm/ Tox Micro- biology Biopharm PAT NCSS OINDP

  8. Future Focus • GMP Initiative - includes manufacturing practices and policies • CBER/CDER Consolidation • Developing policies and practices to regulate new products, new delivery systems, etc.

  9. Future Focus (cont.) • Development and revision of new standards/guidances • Focus on generic products - developing bioequivalence methods, etc. • Evaluation of future PQRI recommendations

  10. Changes in Membership • Sabbatical: • Dr. Venitz • Last Meeting: • Dr. Lee • Dr. Anderson • Dr. Berg • Dr. Doull • Dr. Boehlert • Dr. Jusko

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