Marion Chatfield

Marion Chatfield is a manager in Statistical Sciences at GlaxoSmithKline (Hertfordshire).

Articles

Risk-Based Intermediate Precision Studies for Analytical Procedure Validation

Marion Chatfield;Phil Borman;Fumiko Tamura;Hatsuki Asahara;Adam Watkins

September 15th 2019

Validation of analytical procedures require assessment of the impact of variations within laboratories; however, guidance to study intermediate precision has been lacking. Science and risk-based principles should be used in the design of intermediate precision studies.

Evaluating Progress in Analytical Quality by Design

Elizabeth Hewitt;Andy Rignall;Mark D. Trone;Patrick Jackson;Marion Chatfield;Mark Argentine;Qinggang Wang;Shreekant Karmarkar;Andrea M. Pless;Zeena Williams;Kimber Barnett;David Semin;Yanqun Zhao;Ariane Marolewski

April 2nd 2017

The authors present the results of a survey of small- and large-molecule pharmaceutical and biopharmaceutical companies on implementation of Analytical quality by design concepts.

Analytical Method Comparability in Registration and Post-Approval Stages: A Risk-Based Approach

Frank Diana;Jeff Hofer;Marion Chatfield;Nancy Benz;Yuan Huang;Mark Argentine;Qinggang Wang;Shreekant Karmarkar;Hafez Abdel-Kader;Lakshmy M. Nair;Hui Fang;Theresa Natishan;Andrea M. Pless;Rick Burdick;Zeena Williams

October 2nd 2014

A risk-based approach is recommended for analytical method comparability for HPLC assay and impurities methods.

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

Alice Laures;George Okafo;Patrick Jackson;Phil Borman;Marion Chatfield

April 2nd 2010

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

FMEA tool

Keith Truman;Phil Nethercote;Phil Borman;Marion Chatfield;Duncan Thompson

October 11th 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.