The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.
Apr 2, 2013
By:
Mark Alasandro, Thomas A. Little, Jeffrey Fleitman
The authors describe a method-validation-by-design (MVbD) approach to validate a method over a range of formulations using both design-of-experiment and quality-by-design principles to define a design space that allows for formulation changes without revalidation.
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A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
Nov 3, 2012
By:
Dilip R. Choudhury, Ramesh K. Sood, John Bobiak, Mark Alasandro, Steven W. Baertschi, Bekki Komas, M. J. Skibic, Brian W. Pack, Saji Thomas, Robert H. Seevers, Kim Huynh-Ba, Stephen Colgan, Robert J. Timpano, Ganapathy Mohan, David Lin
A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC. This article summarizes some of the topics presented at the AAPS workshop on various scientific aspects affecting pharmaceutical stability. A full summary can be read online at www.PharmTech.com/AAPSstability. A follow-up AAPS workshop on pharmaceutical stability is being planned for 2013.
Nov 2, 2012
By:
Dilip R. Choudhury, Ramesh K. Sood, John Bobiak, Mark Alasandro, Steven W. Baertschi, Bekki Komas, M. J. Skibic, Brian W. Pack, Saji Thomas, Robert H. Seevers, Kim Huynh-Ba, Stephen Colgan
A two-day workshop on the "science behind pharmaceutical stability" was held in conjunction with the Annual Meeting of American Association of Pharmaceutical Scientists (AAPS) on Oct. 21-22, 2011 in Washington, DC.
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IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
Sep 2, 2012
By:
Bruce Acken, Mark Alasandro, Stephen Colgan, Paul Curry, Frank Diana, Q. Chan Li, Z. Jane Li, Tony Mazzeo, Andy Rignall, Z. Jessica Tan, Robert Timpano
IQ Consortium representatives explore and define common industry approaches and practices for applying GMPs in early development, with a focus on stability.
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