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Method Validation in Pharmaceutical Analysis: A Guide to Best Practice [Hardcover]

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Item description for Method Validation in Pharmaceutical Analysis: A Guide to Best Practice by Joachim Ermer & John H. Miller...

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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Item Specifications...

Pages   403
Est. Packaging Dimensions:   Length: 1" Width: 6.75" Height: 9.5"
Weight:   2.05 lbs.
Binding  Hardcover
Release Date   May 6, 2005
Publisher   Wiley-VCH
ISBN  3527312552  
ISBN13  9783527312559  

Availability  0 units.

More About Joachim Ermer & John H. Miller

Register your artisan biography and upload your photo! Joachim Ermer is Director of Analytical Processes and Technology in Quality Operations, Global Analytical Development of Aventis. He is responsible for supporting and advising the Quality Control sites in analytical aspects, including training. Before joining Hoechst in Frankfurt as Head of Laboratory in Pharma Quality Control Development Products in 1991, he obtained his PhD in biochemistry from University of Halle, Germany in 1988 and worked as research scientist and post-doc fellow at the Universities of Halle and Cambridge, UK. He has a broad experience in analytical activities in pharmaceutical development and quality control, such as method development, specification design, regulatory documentation, etc. His special interests are validation and related topics to achieve robust and reliable analytical procedures.

Joachim Ermer has an academic affiliation as follows - sanofi-aventis, Frankfurt, Germany.

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1Books > Foreign Language Books > German > All German Books
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8Books > Subjects > Professional & Technical > Professional Science > Chemistry > Analytic
9Books > Subjects > Science > Chemistry > Analytic
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