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© 2021 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2021 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Thomas A. Little Consulting and BioAssay Sciences
Thomas A. Little is president, Thomas A. Little Consulting and BioAssay Sciences, 12401 North Wildflower Lane, Highland, Utah 84003, USA, firstname.lastname@example.org.
April 04, 2018
To protect drug product and drug substances, statistical methods to identify critical process parameters and critical material attributes, as well as and approaches to control them, are needed.
July 02, 2014
The right approach can provide a clear, statistically defendable method for determining dissolution and accelerated stability.
April 02, 2013
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.
November 01, 2012
Critical process parameters (CPPs) and their associated process controls are crucial to drug development and process validation and to the evaluation of every manufacturing unit operation.