Food and Drug Administration

Advisory Committee for Pharmaceutical Science

October 25-26, 2005

Briefing Information

1.      Introduction Memorandum to the Committee from Dr. Ajaz Hussain, PhD

2.      Draft Agenda

  1. Achieving and demonstrating “Quality by Design” with respect to drug release/dissolution
    performance for conventional or immediate release solid oral dosage forms

4.      Inherent Method Variability in Dissolution Testing: The Effect of Hydrodynamics in the USP II
Apparatus Calibration Criteria

5.      GPhA Proposed Pathway for Quality by Design Dissolution Testing and Setting of Specifications
for Generic Drugs Therapeutic Equivalence Nomenclature

6.      A PhRMA Perspective on Using a Quality-by-Design Approach for Regulatory Decisions in
Establishing Meaningful Drug Dissolution/Release Specifications While Creating Flexibility for
Continuous Improvement.

  1. USP Position - The USP Performance Test - Systems Suitability Studies

8.      Awareness Topic: Mitigating the Risks of Ethanol Induced Dose Dumping from Oral
Sustained/Controlled Release Dosage Forms

9.      OGD White Paper -- Question-Based Review (QbR) for Generic Drugs: An Enhanced
Pharmaceutical Quality Assessment System

10.   ONDC Pilot Program -- Fr Notice

11.   ONDC Pilot Program -- FR Notice (extension)

  1. ONDC’s New Risk-Based Pharmaceutical Quality Assessment System
  2. Quality-by-Design -- A Perspective from the Office of Biotechnology Products (OBP)

14.  Research Peer-Review at CDER: Past and Present

15.  Current Peer Review Process in the Office of Biotechnology Products

16.  The Nation Needs a Comprehensive Pharmaceutical Engineering Education and Research System  (See Bibliography)

17.  Unleashing the New Pharma Workforce  (See Bibliography)

  1. Abstract: Ensuring the Supply of Highly Qualified Pharmaceutical Scientist Specialists in Product
    Development and Related Technologies for Present and Future Needs
  2. Bibliography