Analytical Method Validation and Instrument Performance Verification

by HermanLam (Editor), Xue-MingZhang (Editor), Y.C.Lee (Editor), Chung Chow Chan (Editor)

• New

  Hardcover
  2004

  $159.22

  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.