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OLS Field Name OLS Field Data
Main Title Analytical method validation and instrument performance verification /
Other Authors
Author Title of a Work
Chan, Chung Chow.
Publisher John Wiley & Sons,
Year Published 2004
OCLC Number 52514343
ISBN 0471259535; 9780471259534
Subjects Drugs--Analysis--Methodology--Evaluation. ; Laboratories--Equipment and supplies--Evaluation. ; Laboratories--Instruments--Evaluation. ; Chemistry, Pharmaceutical--instrumentation. ; Chemistry, Pharmaceutical--methods. ; Technology, Pharmaceutical--methods. ; Clinical Laboratory Techniques--standards. ; Produits pharmaceutiques. ; Equipement de recherche. ; Méthodes de recherche. ; Normes de qualité. ; Contrãole de qualité. ; Química farmacãeutica (métodos)
Internet Access
Description Access URL
Contributor biographical information
Publisher description
Library Call Number Additional Info Location Last
EOBM  RS189.A56 2004 NEIC Library/Denver,CO 01/21/2005
Collation x, 303 pages : illustrations ; 24 cm
Includes bibliographical references and index.
Contents Notes
Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen -- Potency method validation / Chung Chow Chan -- Method validation for HPLC analysis of related substances in pharmaceutical drug products / YC Lee -- Dissolution method validation / Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, Y.C. Lee. Development and validation of automated methods / Chantal Incledon and Herman Lam -- The analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang -- Validation study of JP heavy metal limit test / Yoshiki Nishiyama -- Bioanalytical method validation / Fabio Garofolo. The procurement, qualification and calibration of laboratory instruments: an overview / Herman Lam -- Performance verification of UV-VIS spectrophotometers / Herman Lam -- Performance verification of HPLC / Herman Lam. Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated labs.