Nicholas Murray Thomson
Pfizer
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Publication
Featured researches published by Nicholas Murray Thomson.
Journal of Pharmaceutical Innovation | 2013
Timothy J. N. Watson; Holly Bonsignore; Eileen A. Callaghan-Manning; Stephen T. Colgan; Paul Fitzsimons; Thomas Garcia; John Groskoph; Michael P. Lynch; Roger Nosal; Megan E. McMahon; Robert A. Singer; Nicholas Murray Thomson; Gregory W. Sluggett; Darren John Schulz; Shirley Twohig
Regulatory expectations regarding design space verification in the designated manufacturing facility at commercial scale are not consistent across global markets. The extent and level of verification of design space boundaries are (a) predicated on the degree of risk and impact of that risk for movement within the design space and (b) are continually evaluated over the life cycle of a product and not necessarily defined as a moment in time (such as a submission date). Additionally, accommodations for differences in scientific disciplines are also important when determining design space verification strategies, for example design space verification approaches may vary between large molecule vs. small molecule drug substance, drug product, batch processes, continuous flow processes, or to assess device performance in combination products, etc. Several strategies and guiding principles to illustrate multiple opportunities and possibilities for the different disciplines to achieve design space verification using sound science and riskbased processes and procedures have recently been published [1, 2]. This publication will present a specific case study for assuring consistent quality within a design space for a recent small molecule drug substance example (of which elements are applicable across the other disciplines). It is not practical to execute and/or repeat experiments at commercial scale in a manufacturing facility to verify design space boundaries when the benefits are nebulous and the cost is prohibitive. Based on suggestions from regulatory authorities, a protocol was prepared to describe the life cycle approach and process for demonstrating design space verification. Publishing this protocol is intended to share the results of a successful interaction with regulators while continuing to facilitate open communication and opportunities for addressing the concept of design space verification. The protocol is presented within Appendix 1.
Archive | 2005
Alan Daniel Brown; Mark Edward Bunnage; Paul A. Glossop; Kim James; Charlotte Alice Louise Lane; Russell Andrew Lewthwaite; Ian Brian Moses; David A. Price; Nicholas Murray Thomson
Organic Process Research & Development | 2005
Christopher P. Ashcroft; Stephen Challenger; David Clifford; Andrew Michael Derrick; Yousef Hajikarimian; Keith Slucock; Terry V. Silk; Nicholas Murray Thomson; John R. Williams
Organic Process Research & Development | 2003
Christopher P. Ashcroft; Stephen Challenger; Andrew Michael Derrick; Richard Storey; Nicholas Murray Thomson
Archive | 2000
Simon Bailey; Stephane Billotte; Andrew Michael Derrick; Paul V. Fish; Kim James; Nicholas Murray Thomson
Journal of Molecular Catalysis A-chemical | 2008
Shifang Liu; Nicholas Murray Thomson; Alan Pettman; Zeynab Hyder; Jun Mo; Jianliang Xiao
Archive | 2001
Mark Edward Bunnage; Philip Charles Levett; Nicholas Murray Thomson
Archive | 2003
Mark Edward Bunnage; Philip Charles Levett; Nicholas Murray Thomson
Archive | 2002
Andrew Michael Derrick; Nicholas Murray Thomson
Archive | 2002
Andrew Michael Derrick; Nicholas Murray Thomson