Bibliography
Advisory Committee for Pharmaceutical Science
April 13-14, 2004
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Initiative on Pharmaceutical Quality Systems for the 21st Century and the Debate on Delivered Dose
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- Schadt,
Randall, "Process Analytical Technology - Changing the Validation
Paradigm", American Pharmaceutical Review, Vol. 7, Issue 1
(2004): 58-61
- Cooley, Rick
E., Egan, J. Carmel, "The Impact of Process Analytical Technology
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- Arrivo, Steven M., "The
role of PAT in Research and Development", American Pharmaceutical
Review, Vol. 6, Issue 2 (2003): 46-53
- Tothfalusi, Laszlo, Endrenyi,
Laszlo, “Limits for the Scaled
Average Bioequivalence of Highly Variable Drugs and Drug Products” Pharmaceutical
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- 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]