Articles by Thomas A. Little - Pharmaceutical Technology

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Articles by Thomas A. Little

Thomas A. Little


Thomas A. Little, PhD, is president of Thomas A. Little Consulting, 12401 N Wildflower Lane, Highland, UT 84003, tel. 925.285.1847, drlittle@dr-tom.com

Articles
Method Validation by Design to Support Formulation Development
April 2, 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.

Using a Systematic Approach to Select Critical Process Parameters
November 1, 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.

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