Ermer J., Miller J.H. McB. Method Validation in Pharmaceutical Analysis

Ermer J., Miller J.H. McB. Method Validation in Pharmaceutical Analysis
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  • добавлен 17.09.2011
2005, WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim, - 411 стр
Contents:
Preface V
List of Contributors XIII
Fundamentals of Validation in Pharmaceutical Analysis
Analytical Validation within the Pharmaceutical Environment
Joachim Ermer
Regulatory Requirements
ntegrated and Continuous Validation
General Planning and Design of Validation Studies
Always Look on the Routine’ Side of Validation
Evaluation and Acceptance Criteria
What does Suitability Mean?
Statistical Tests
Key Points
Performance Parameters, Calculations and Tests
Precision
Joachim Ermer
Parameters Describing the Distribution of Analytical Data
Precision Levels
Acceptable Ranges for Precisions
Sources to Obtain and Supplement Precisions
Key Points
Specificity
Joachim Ermer
Demonstration of Specificity by Accuracy
Chromatographic Resolution
Peak Purity (Co-elution)
Key Points
Case Study: Validation of an HPLC-Method for Identity,
Assay, and Related Impurities
Part II Life-cycle Approach to Analytical Validation
Qualification of Analytical Equipment
Validation During Drug Product Development – Considerations
as a Function of the Stage of Drug Development
Acceptance Criteria and Analytical Variability
Transfer of Analytical Procedures
Validation of Pharmacopoeial Methods
Analytical Procedures in a Quality Control Environment
Aberrant or Atypical Results
Future Trends in Analytical Method Validation

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