Analytical Method Validation and Instrument Performance Verification

　　作者：Chan 作者：Chung Chow (EDT)/ Lam 作者：Herman (EDT)/ Lee 作者：Y. C. (EDT)/ Zhang 作者：Xue-Ming (EDT) F

　　出版社：John Wiley & Sons Inc

　　ISBN号：047125953

　　页数：316 o1kTB&E4B

　　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