Analytical Method Validation and Instrument Performance Verification |
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| Editor:
| Chan, Chung Chow
Lee, Y. C.
Lam, Herman
Zhang, Xue-Ming |
| ISBN: | 978-0-471-25953-4 |
| Publication Date: | Jan 2004 |
| Publisher: | John Wiley & Sons, Incorporated
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| Imprint: | Wiley-Interscience |
| Book Format: | Hardback |
| List Price: | AUD $288.95 |
Book Description:
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Provides an all-round discussion of the regulatory requirements of FDA, ICH, Europe, and Japan as they pertain to calibration of instruments and validation of methods.
- Gives practical tips on how to validate techniques.
- Explains why different approaches are necessary in biopharmaceutical and bioanalytical methods validation.
Provides an all-round discussion of the regulatory requirements of FDA, ICH, Europe, and Japan as they pertain to calibration of instruments and validation of methods.
- Gives practical tips on how to validate techniques.
- Explains why different approaches are necessary in biopharmaceutical and bioanalytical methods validation.