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Analytical Method Validation and Instrument Performance Verification PDF

316 Pages·2004·3.446 MB·English
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by Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang| 2004| 316 pages| 3.446| English

About 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 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.

Detailed Information

Author:Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang
Publication Year:2004
ISBN:471259535
Pages:316
Language:English
File Size:3.446
Format:PDF
Price:FREE
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