Articles by Alice Laures - Pharmaceutical Technology

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Articles by Alice Laures

Reduced-Method Robustness Testing of Analytical Methods Driven by a Risk-Based Approach

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material.
Apr 2, 2010

The authors describe a novel approach for assessing method robustness. This article contains online-bonus material and was copublished with Pharmaceutical Technology Europe.

Reduced method robustness testing of analytical methods driven by a risk-based approach

A novel approach for assessing method robustness is described that uses risk-based assessment tools to identify, score, prioritise and then group method parameters. These parameters are then studied using reduced fractional factorial designs (termed Reduced Method Robustness) to evaluate the suitability of analytical methods prior to full validation. This simple approach helps to identify high risk method parameters earlier and can potentially save resource later in the development process.
Mar 30, 2010

A novel approach for assessing method robustness is described that uses risk-based assessment tools to identify, score, prioritise and then group method parameters.

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