analytical validation von chan lam (6 Ergebnisse)

HRD. Zustand: New. New Book. Shipped from UK. Established seller since 2000.

Zustand: New. pp. x + 303 Illus.

Zustand: New. 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 Pharm.

Hardcover. Zustand: Brand New. 1st edition. 316 pages. 9.25x6.25x1.00 inches. In Stock.

Zustand: New. 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. . 2004. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland.

Buch. Zustand: Neu. Neuware - 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.