Analytical Method Validation

Selective and sensitive analytical methods for the quantitative evaluation of drugs and their metabolites (analytes) are critical for the successful conduct of preclinical and/or biopharmaceutics and clinical pharmacology studies. Analytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given matrix is reliable and reproducible for the intended use.

The fundamental parameters for this validation include:

• accuracy
• precision
• selectivity
• sensitivity
• reproducibility and 
• stability

Validation involves documenting, through the use of specific laboratory investigations, that the performance characteristics of the method are suitable and reliable for the intended analytical applications. The acceptability of analytical data corresponds directly to the criteria used to validate the method.

º  from the FDA website - Analytical Method Validation: Industry Guidance

Analytic Advisors offers a SHORT COURSE PROGRAM developed by Prof. Ira Krull (Northeastern University, Boston MA) and Dr. Michael Swartz (Ariad Pharmaceuticals, Cambridge MA). Both authors can provide experienced coaching and in-house training classes for method development (HPLC) and transfer for full- partial and cross validation of methods.

[Please inquire for further details]