Bioanalytical Method Validation: a Risk-Based Approach?

Bioanalysis frequently involves the measurement of very low analyte concentrations in complex and potentially variable matrices. It is not possible to test in validation every possible circumstance that may be encountered when analyzing study samples; logically, therefore, some risk of obtaining erroneous results exists when validated methods are applied to study samples. An initial attempt has been made to apply a risk management tool to the bioanalytical situation, with the hope that this will stimulate further discussion on the idea of more formally addressing “risk” with regards to bioanalytical method validation.