Articles by Marion Chatfield - Pharmaceutical Technology

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Articles by Marion Chatfield

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.

FMEA tool

Oct 11, 2007

This downloadable Failure Mode Effect Analysis tool accompanies the article titled 'The Application of Quality by Design to Analytical Methods' by Phil Borman et. al.

The Application of Quality by Design to Analytical Methods

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.

This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).

Oct 2, 2007

To monitor and control processes or products, analytical methodology must be fit for purpose. An approach to apply quality by design principles to the design and evaluation of analytical methods has therefore been developed to meet these needs.

This article features a downloadable template on which to conduct a failure mode effect analysis (FMEA).

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