Call Boomerang Books 1300 36 33 32

Description - Method Validation in Pharmaceutical Analysis by Joachim Ermer

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.

Buy Method Validation in Pharmaceutical Analysis by Joachim Ermer from Australia's Online Independent Bookstore, Boomerang Books.

Book Details

ISBN: 9783527312559
ISBN-10: 3527312552
Format: Hardback
(243mm x 176mm x 28mm)
Pages: 418
Imprint: Wiley-VCH Verlag GmbH
Publisher: Wiley-VCH Verlag GmbH
Publish Date: 15-Feb-2005
Country of Publication: Germany

Other Editions - Method Validation in Pharmaceutical Analysis by Joachim Ermer

Book Reviews - Method Validation in Pharmaceutical Analysis by Joachim Ermer

» Have you read this book? We'd like to know what you think about it - write a review about Method Validation in Pharmaceutical Analysis book by Joachim Ermer and you'll earn 50c in Boomerang Bucks loyalty dollars (you must be a Boomerang Books Account Holder - it's free to sign up and there are great benefits!)

Write Review

Author Biography - Joachim Ermer

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.