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Analytical method validation and instrument performance verification

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 ins...

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Bibliographic Details
Group Author: Chan, Chung Chow
Published:
Literature type: Electronic eBook
Language: English
Subjects:
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
Medicine
Pharmacy
TECHNOLOGY & ENGINEERING > Biomedical
MEDICAL > Family & General Practice
MEDICAL > Allied Health Services > Medical Technology
MEDICAL > Biotechnology
MEDICAL > Lasers in Medicine
Electronic books
Online Access: http://onlinelibrary.wiley.com/book/10.1002/0471463728
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
Carrier Form: 1 online resource (x, 303 pages) : illustrations
Bibliography: Includes bibliographical references and index.
ISBN: 047146371X
9780471463719
9780471463726
0471463728
0471259535
9780471259534
Index Number: RS189
CLC: R-33
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.

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