UID:
almafu_9959327122002883
Format:
1 online resource (xiv, 403 pages) :
,
illustrations (some color), portraits
ISBN:
3527604472
,
9783527604470
,
9783527604685
,
3527604685
,
9783527312559
,
3527312552
Content:
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-
Note:
Analytical validation within the pharmaceutical environment / Joachim Ermer -- Performance parameters, calculations and tests / Joachim Ermer, Christopher Burgess, Gerd Kleinschmidt, John H. McB. Miller -- Case study : validation of an HPLC-method for identity, assay, and related impurities / Gerd Kleinschmidt -- Qualification of analytical equipment / David Rudd -- Validation during drug product development : considerations as a function of the stage of drug development / Martin Bloch -- Acceptance criteria and analytical variability / Hermann Wätzig -- Transfer of analytical procedures / Mark Broughton, Joachim Ermer -- Validation of pharmacopoeial methods / John H. McB. Miller -- Analytical procedures in a quality control environment / Raymond A. Cox -- Aberrant or atypical results / Christopher Burgess -- Future trends in analytical method validation / David Rudd.
Additional Edition:
Print version: Method validation in pharmaceutical analysis. Weinheim : Wiley-VCH, ©2005 ISBN 3527312552
Language:
English
Keywords:
Electronic books.
URL:
https://onlinelibrary.wiley.com/doi/book/10.1002/3527604685
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