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Method Validation in Pharmaceutical Analysis [2005]

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