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Method Validation in Pharmaceutical Analysis [2005]
- 1
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Analytical Validation within the Pharmaceutical Environment
- 21
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Performance Parameters, Calculations and Tests
- 195
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Case Study: Validation of An HPLC‐Method for Identity, Assay, and Related Impurities
- 213
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References Part I
- 227
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Qualification of Analytical Equipment
- 243
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Validation During Drug Product Development – Considerations as a Function of the Stage of Drug Development
- 265
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Acceptance Criteria and Analytical Variability
- 281
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Transfer of Analytical Procedures
- 301
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Validation of Pharmacopoeial Methods
- 337
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Analytical Procedures in a Quality Control Environment
- 355
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Aberrant or Atypical Results
- 387
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Future Trends in Analytical Method Validation
- 399
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Index
- i
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Front Matter