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zlib/Medicine/Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang/Analytical Method Validation and Instrument Performance Verification_528805.pdf
Analytical Method Validation and Instrument Performance Verification 🔍
Chung Chow Chan, Y. C. Lee, Herman Lam, Xue-Ming Zhang Wiley-Interscience, 1, 2004-01-28
英语 [en] · PDF · 19.4MB · 2004 · 📘 非小说类图书 · 🚀/lgli/lgrs/zlib · Save
描述
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.
备选标题
Analytical method validation and instrument calibration
备选作者
edited by Chung Chow Chan ... [et al.]
备用出版商
Jossey-Bass, Incorporated Publishers
备用出版商
John Wiley & Sons, Incorporated
备用出版商
WILEY COMPUTING Publisher
备用版本
John Wiley & Sons, Inc., Hoboken, N.J., 2004
备用版本
United States, United States of America
备用版本
Hoboken, NJ, United States, 2004
备用版本
Hoboken, N.J, New Jersey, 2004
备用版本
January 28, 2004
备用版本
New York, 2004
备用版本
1, PS, 2004
元数据中的注释
ihtik -- 1
元数据中的注释
lg97248
元数据中的注释
Includes bibliographical references and index.
备用描述
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 / Y.C. Lee
Dissolution method validation / Chung Chow Chan ... [et al.].
Development and validation of automated methods / Chantal Incledon and Herman Lam
Analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang
Validation study of JP heavy metal limit test / Yoshiki Nishiyama
Bioanalytical method validation / Fabio Garofolo
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
Operational qualification of a capillary electrophoresis instrument / Nicole E. Baryla
LC-MS instrument calibration / Fabio Garofolo
Karl Fisher apparatus and its performance verification / Rick Jairam, Robert Metcalfe, and Yu-Hong Tse
The pH meter and its performance verification / Yu-Hong Tse, Rick Jairam, and Robert Metcalfe
Qualification of environmental chambers / Gilman Wong and Herman Lam
Equipment qualification and computer system valication / Ludwig Huber
Validation of Excel spreadsheet / Heiko Brunner.
备用描述
Pharmaceutical product development consists of a series of logical and systematic processes.
开源日期
2009-07-20
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