Articles by Thomas A. Little - Pharmaceutical Technology

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Articles by Thomas A. Little

Method Validation by Design to Support Formulation Development

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

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

Harmonized regulations call for a risk-based and systematic approach to evaluating and selecting CPPs for accurate process control. 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.
Nov 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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