Advisory Committee for Pharmaceutical Science

April 13-14, 2004




  1. Hussain, Ajaz S., "FDA's Initiative on Pharmaceutical Quality Systems for the 21st   Century and the Debate on Delivered Dose Uniformity for Inhalers", prepared for submission to Respiratory Drug Delivery IX, p. 1-12 [Not yet published]


  1. Schadt, Randall, "Process Analytical Technology - Changing the Validation Paradigm", American Pharmaceutical Review, Vol. 7, Issue 1 (2004): 58-61


  1. Cooley, Rick E., Egan, J. Carmel, "The Impact of Process Analytical Technology (PAT) on Pharmaceutical Manufacturing", American Pharmaceutical Review, Vol. 7, Issue 1 (2004): 62-68


  1. Arrivo, Steven M., "The role of PAT in Research and Development", American Pharmaceutical Review, Vol. 6, Issue 2 (2003): 46-53


  1. Tothfalusi, Laszlo, Endrenyi, Laszlo,  “Limits for the Scaled Average Bioequivalence of Highly Variable Drugs and Drug Products”  Pharmaceutical Research, Vol. 20, No. 3, (March 2003): 382-389


  1. Lionberger, Robert A., Lawrence X, Yu, et. al., "Development of Bioequivalence Methods for Topical Dermatological Drug Products",  prepared for submission to Pharmaceutical Research, p. 1-32

     [Not yet published]