Method Validation in Pharmaceutical Analysis
A Guide to Best Practice
1. Edition January 2005
XIV, 404 Pages, Hardcover
138 Pictures (9 Colored Figures)
99 tables
Practical Approach Book
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.
- Out of print -
Further versions
Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness.
Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends.
With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
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
BTS Newsletter, Summer 2005
"This book fills a gap for a comprehensive, comprehensible and illustrative guidebook and reference on current method validation in pharmaceutical analysis. I would thoroughly recommend purchase of this book which I would anticipate will become highly cited over the coming years."
Chromatographia
"...a well-written textbook with well-organized chapters...extensively referenced from world-renowned experts in the field."
E-STREAMS
