Method Validation in Pharmaceutical Analysis is a practical reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities. The authors, with their first-hand knowledge of both the industry and regulating bodies, interpret in detail existing regulations, while discussing the appropriate calculations, parameters and tests. The book thus allows readers to comply with the regulations as well as with the industry demands for speed and low costs.

Contents

• Analytical Validation within the Pharmaceutical Environment
• Performance Parameters, Calculations and Tests
• Case Study: Validation of an HPLC-Method for Identity, Assay, and Related Impurities
• 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 Pharmacopeial Methods
• Analytical Procedures in a Quality Control Environment
• Aberrant or Atypical Results
• Future Trends in Analytical Method Validation

Index

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ORDER NOW Method Validation in Pharmaceutical Analysis A Guide to Best Practice edited by Joachim Ermer 2005 • 403 pages • $240.00 + shipping Texas residents please add 6.75 % sales tax