Method validation in pharmaceutical analysis: a guide to best practice
Gespeichert in:
Bibliographische Detailangaben
Format: Elektronisch E-Book
Sprache:English
Veröffentlicht: Weinheim Wiley-VCH ©2005
Schlagworte:
Online-Zugang:FRO01
UBG01
URL des Erstveröffentlichers
Beschreibung:Includes bibliographical references and index
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-
Beschreibung:1 Online-Ressource (xiv, 403 pages)
ISBN:3527604472
9783527604470
9783527604685
3527604685
3527312552

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