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OverviewAdopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness.Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities. Full Product DetailsAuthor: J Ermer , Joachim Ermer (sanofi-aventis, Frankfurt, Germany) , John H McB Miller (European Directorate for the Quality of Medicines (EDQM), Strasbourg, France)Publisher: Wiley-Vch Imprint: Wiley-Vch ISBN: 9781280519772ISBN 10: 1280519770 Pages: 403 Publication Date: 01 January 2006 Audience: General/trade , General Format: Electronic book text Publisher's Status: Active Availability: In stock  We have confirmation that this item is in stock with the supplier. It will be ordered in for you and dispatched immediately. Table of ContentsReviewsAuthor InformationTab Content 6Author Website:Countries AvailableAll regions |
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