Food
and Drug Administration
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Draft Guidance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