Validation of Analytical Methods for Pharmaceutical Analysis

This book provides a comprehensive guide on validating analytical methods. Key features: Full review of the available regulatory guidelines on validation and in particular, ICH. Sections of the guideline, Q2(R1), have been reproduced in this book with the kind permission of the ICH Secretariat; Thorough discussion of each of the validation characteristics (Specificity; Linearity; Range; Accuracy; Precision; Detection Limit; Quantitation Limit; Robustness; System Suitability) plus practical tips on how they may be studied; What to include in a validation protocol with advice on the experimental procedure to follow and selection of appropriate acceptance criteria; How to interpret and calculate the results of a validation study including the use of suitable statistical calculations; A fully explained case study demonstrating how to plan a validation study, what to include in the protocol, experiments to perform, setting acceptance criteria, interpretation of the results and reporting the study.

Author: Oona McPolin
Publisher: Mourne Training Services
Published: 05/06/2009
Pages: 152
Binding Type: Paperback
Weight: 0.84lbs
Size: 11.69h x 8.27w x 0.33d
ISBN: 9780956152817

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