The objective of method validation is to demonstrate that procedures you use are suitable for their intended purpose. Selective and sensitive methods for the quantitative evaluation of drugs and their metabolites are critical for the successful conduct of preclinical and/or biopharmaceutics and clinical pharmacology studies, therefore having confidence in method results are essential in safety research as well as many other research outlets. Method validation includes systematically assessing the procedures to demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine, is reliable and reproducible for the intended use.
The fundamental parameters for this validation include (1) accuracy, (2) precision, (3) selectivity, (4) sensitivity, (5) reproducibility, and (6) stability. Validation involves planning and documenting, through the use of specific laboratory investigations, that the performance characteristics of the method are suitable and reliable for the intended applications. The acceptability of the data corresponds directly to the criteria used to validate the method.
US Regulatory References / Guidances
- FDA Guidance for Industry for Bioanalytical Method Validation
- FDA Guidance for Industry for Analytical Procedures and Methods Validation for Drugs and Biologics