Method Validation in Pharmaceutical Analysis : A Guide to Best Practice. Joachim Ermer, John H. McB. Miller

Method Validation in Pharmaceutical Analysis : A Guide to Best Practice


Method.Validation.in.Pharmaceutical.Analysis.A.Guide.to.Best.Practice.pdf
ISBN: 3527312552,9783527604470 | 418 pages | 21 Mb

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Method Validation in Pharmaceutical Analysis : A Guide to Best Practice Joachim Ermer, John H. McB. Miller
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Review

"…a well-written textbook with well-organized chapters…extensively referenced from world-renowned experts in the field." (E-STREAMS, September 2005)

“ … the book contains a number of case studies and this brings the subject to life.”  (BTS Newsletter, Summer 2005)

From the Back Cover

Adopting 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.



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