Articles by Phil Borman - Pharmaceutical Technology

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Articles by Phil Borman

Quantitative open-access HPLC analysis: a new calibration approach

Oct 1, 2010

A novel tool enables users to generate reliable data for yields in solution and for assays of isolated solids using high?performance liquid chromatography without having to prepare standards.

Quantitative Open-Access HPLC Analysis

The authors discuss the approach taken to develop a new calibration approach, its associated protocols, and how it can be used to calculate data.
Oct 1, 2010

The authors discuss the approach taken to develop a new calibration approach, its associated protocols, and how it can be used to calculate data.

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.

Implications and Opportunities of Applying QbD Principles to Analytical Measurements

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.
Feb 2, 2010

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods. This article contain bonus online material.

Implications and Opportunities of Applying QbD Principles to Analytical Measurements

Feb 1, 2010

The authors present two concepts to improve robustness and facilitate continuous improvement in analytical methods.

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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