SciTech Book News , 06/01/2005 29 2
Method validation in pharmaceutical analysis; a guide to best practice.(THERAPEUTICS, PHARMACOLOGY)(Brief Article)(Book Review)
COPYRIGHT 2005 Book News, Inc.
RS189 3-527-31255-2
Method validation in pharmaceutical analysis; a guide to best practice.
Title main entry. Ed. by Joachim Ermer and John H. McB. Miller.
Wiley-VCH, [c]2005
403 p.
$195.00
Ermer, a quality control expert, and Miller (European Directorate for the Quality of Medicine) provide a detailed interpretation of the existing GMP and ICH regulations for pharmaceutical analysis, and discuss relevant calculations, parameters, and tests. The authors focus on a life-cycle approach to validation and the integration of validation into the entire analytical quality assurance system. The book will allow analytical chemists and pharmaceutists to validate the analysis of pharmaceutical compounds while complying with regulations and industry demands for robustness and cost effectiveness.
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