1. Edition - January 2005
199.- Euro
2005. XIV, 404 Pages, Hardcover
138 Fig. (9 Colored Fig.), 99 Tab. 
- Practical Approach Book -
ISBN-10: 3-527-31255-2
ISBN-13: 978-3-527-31255-9 - Wiley-VCH, Weinheim






Sample Chapter



Short description
With their first-hand knowledge of both the industry and regulating bodies, the authors 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.
A practical reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

From the 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