Joachim (Hrsg.) Ermer

Method Validation in Pharmaceutical Analysis

A Guide to Best Practice

Ebook (PDF Format)

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 o… Mehr

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Produktdetails

Weitere Autoren: Miller, John H. McB. (Hrsg.)

ISBN: 978-3-527-60447-0
EAN: 9783527604470
Produktnummer: 13897531
Verlag: Wiley-Vch
Sprache: Englisch
Erscheinungsjahr: 2006
Seitenangabe: 418 S.
Plattform: PDF
Masse: 3'225 KB

Über den Autor

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.