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Analytical Method Validation and Instrument Performance Verification
CC Chan
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Analytical Method Validation and Instrument Performance Verification
CC Chan
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.
320 pages, index
Media | Bøker Innbunden bok (Bok med hard rygg og stivt omslag) |
Utgitt | 25. februar 2004 |
ISBN13 | 9780471259534 |
Utgivere | John Wiley & Sons Inc |
Antall sider | 320 |
Mål | 164 × 236 × 24 mm · 597 g |
Språk | Engelsk |
Redaktør | Chan, Chung Chow (Eli Lilly Canada, Inc., Canada ) |
Redaktør | Lam, Herman (GlaxoSmithKline Canada, Inc.) |
Redaktør | Lee, Y. C. (Patheon YM, Inc., Canada) |
Redaktør | Zhang, Xue-Ming (Novex Pharma, Canada) |