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Analytical Method Validation and Instrument Performance Verification
Chan
€ 168.99
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Description for Analytical Method Validation and Instrument Performance Verification
Hardcover. Provides a discussion of the regulatory requirements of FDA, ICH, Europe, and Japan as they pertain to calibration of instruments and validation of methods. This book offers practical tips on how to validate techniques. It explains why different approaches are necessary in biopharmaceutical and bioanalytical methods validation. Editor(s): Chan, Chung Chow; Lee, Y. C.; Lam, Herman; Zhang, Xue-Ming. Num Pages: 320 pages, index. BIC Classification: PDN; PN; TDCW. Category: (P) Professional & Vocational. Dimension: 236 x 162 x 21. Weight in Grams: 586.
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 ... Read more
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 ... Read more
Product Details
Format
Hardback
Publication date
2004
Publisher
John Wiley & Sons Inc United States
Number of pages
320
Condition
New
Number of Pages
320
Place of Publication
, United States
ISBN
9780471259534
SKU
V9780471259534
Shipping Time
Usually ships in 7 to 11 working days
Ref
99-50
About Chan
CHUNG CHOW CHAN is a Research Scientist at Eli Lilly Canada, Inc. Y. C. LEE is the associate director of Patheon YM, Inc., in Canada. HERMAN LAM is Manager of Automation and Lab Systems at Glaxo Smith Kline Canada. XUE-MING ZHANG is a Supervisor at Novex Pharma. Chung Chow, Herman, and Y. C. are the ... Read more
Reviews for Analytical Method Validation and Instrument Performance Verification
“It is a treasure of helpful hints and techniques which can aid even experienced analysts through some of the ICH procedures.” (Metrohm Information, 4th July 2005) "While most useful for pharmaceutical laboratories, it may also be useful in certain university and government laboratories." (E-STREAMS, February 2005) "…a treasure of helpful hints and techniques that can aid even ... Read more