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

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  helped in making decision to withdraw draft
  guidance and focus on more general bioequivalence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

• Last Meeting
• Dr. Lee
• Dr. Anderson
• Dr. Berg
• Dr. Doull
• Dr. Boehlert
• Dr. Jusko

• Sabbatical
• Dr. Venitz

11
(No Transcript)
12
(No Transcript)
13
(No Transcript)
14
(No Transcript)