LABORATORY FOR VALIDATION OF ANALYSIS METHOD
Learning outcomes of the course unit
To provide the concept for data processing during the validation of analytical methods.
Course contents summary
Laboratory practice based on the evaluation of: precision, accuracy, linearity, limits of detection and quantification following both the Eurachem and the ICH guidelines.
handbook UNICHIM 179/1, UNICHIM, Milano
handbook UNICHIM 179/2, UNICHIM, Milano
The Fitness for Purpose of Analytical Methods: A Laboratory Guide to Method Validation and Related Topics, EURACHEM Guide, 1st English Edition 1.0-1998, LGC (Teddington) Ltd., http://www.eurachem.ul.pt/
ICH Q2A: Text on Validation of Analytical Procedures, 1994
ICH Q2B: Validation of Analytical Procedures: Methodology, 1996