Bibliography

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: http://www.fda.gov/oc/initiatives/criticalpath/

 

2. 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 21^st Century -- A Risk-based Approach Final Report".  FDA report available on the FDA Website: http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.htm

 

2. "Innovation and Continuous Improvement in Pharmaceutical Manufacturing".  FDA report available on the FDA Website: http://www.fda.gov/cder/gmp/gmp2004/manufSciWP.pdf

 

3. 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.