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Title Analytical method validation and instrument performance verification / edited by Chung Chow Chan [and others]
Published Hoboken, N.J. : John Wiley & Sons, ©2004


Description 1 online resource (x, 303 pages) : illustrations
Contents 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
Summary 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 lab s
Bibliography Includes bibliographical references and index
Notes Print version record
Subject Drugs -- Analysis -- Methodology -- Evaluation
Laboratories -- Equipment and supplies -- Evaluation
Laboratories -- Instruments -- Evaluation
Chemistry, Pharmaceutical -- instrumentation
Chemistry, Pharmaceutical -- methods
Clinical Laboratory Techniques -- standards
Technology, Pharmaceutical -- methods
MEDICAL -- Family & General Practice.
MEDICAL -- Allied Health Services -- Medical Technology.
MEDICAL -- Biotechnology.
MEDICAL -- Lasers in Medicine.
Form Electronic book
Author Chan, Chung Chow.
ISBN 047146371X