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Analytical Method Validation and Instrument Performance Verification

Analytical Method Validation and Instrument Performance Verification

Chung Chow Chan, Herman Lam, Y. C. Lee, Xue-Ming Zhang

Wiley-Interscience
Publication date : 2004-04-23

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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 setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.

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About the book

Author

Chung Chow Chan , Herman Lam , Y. C. Lee , Xue-Ming Zhang

Imprint

Wiley-Interscience

Collection

n.c

Publication date

2004-04-23

Pages

320 pages

Print ISBN

9780471259534

Language

English

Ebook informations

EAN PDF

9780471463719

Price

£161.94

Copy count 0

Print count 320

File size 2079 Ko

Informations accessibility

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About author(s)

Chung Chow Chan

Herman Lam

Y. C. Lee

Xue-Ming Zhang

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