Advisory Committee for Pharmaceutical Science

October 19-20, 2004



Day 1: Tuesday, October 19, 2004


   Critical Path Initiative -- Challenges and Opportunities


  1. "Challenge and Opportunity on the Critical Path to New Medical Products". FDA white paper available on the FDA Website:


  1. Bush, Laura, "From CGMPs to the Critical Path -- FDA Focuses on Innovation, Quality, and Continuous Improvement—Inside and Out", Pharmaceutical Technology, July 2004, p. 34-44. [Reprinted by permission of the author]


Day 2: Wednesday, October 20, 2004


   "Desired State" -- OPS Moving Forward


  1. "Pharmaceutical cGMPs for the 21st Century -- A Risk-based Approach Final Report".  FDA report available on the FDA Website:


  1. "Innovation and Continuous Improvement in Pharmaceutical Manufacturing".  FDA report available on the FDA Website:


  1. Leuenberger, H., Lanz, M, "Pharmaceutical Powder Technology – from Art to Science: the challenge of FDA’s PAT initiative", Advanced Powder Technology, Volume 16, No.1, February 2005 (in press). [Not yet published -- preprint copy provided by permission] of the Chief Editor]


   Bioequivalence of Generic Drugs


  1. Hayes, S. N., Dunne, A., Smart, T., Davis, J., "Interpretation and Optimization of the Dissolution Specifications for a Modified Release Product with an In Vivo–In Vitro Correlation (IVIVC)", Journal of Pharmaceutical Sciences, Vo. 93, No.3, March 2004, p. 571-581.