Food and Drug Administration

Advisory Committee for Pharmaceutical Science

May 3-4, 2005

Briefing Information

 

Introduction Memorandum to the Committee from Dr. Ajaz Hussain, PhD
[Word] [PDF] [HTML]

 

Draft Agenda
[Word] [PDF] [HTML]

 

Quality-by-Design Approach for Regulatory Decisions: Seeking Applications for Establishing Drug Dissolution/Release Specifications, Creating Flexibility for Continuous Improvement and for Assessment of Therapeutic Equivalence
[Word] [PDF] [HTML]

 

Presentation on ICH Q8 Pharmaceutical Development: Draft Guidance
[HTML] [PPT]

 

Dissolution Apparatus History and Sources of Variability
[Word] [PDF] [HTML]

 

Calibration Criteria
[Word] [PDF] [HTML]

 

Therapeutic Equivalence Nomenclature
[Word] [PDF] [HTML]

 

Bioequivalence Requirements for Highly Variable Drugs and drug Products
[Word] [PDF] [HTML]

 

Topical Bioequivalence Update
[HTML] [PPT]

 

Current Peer Review Process in the Office of Biotechnology Products
[Word] [PDF] [HTML]

 

Research Peer Review at CDER: Past and Present
[Word] [PDF] [HTML]

 

Bibliography

[Word] [PDF] [HTML]