International Guidelines for Bioanalytical Method Validation: A Comparison and Discussion on Current Scenario

Abstract

US FDA released guidelines for bioanalytical method validation in 2001 and it became the basis for guidelines such as ANVISA and EMA. Even though there is a general agreement between these guidelines in terms of evaluation of validation parameters, significant diversity exists with respect to methodology employed. Present review compares and summarizes the regulatory guidelines issued by US FDA, ANVISA and EMA for bioanalytical method validation. This review also discusses evaluation of certain validation parameters such as matrix effect, incurred sample reanalysis, various stability aspects, effect of anticoagulant counter ions, specificity in the presence of concomitant medications, and identification of pharmacokinetic repeats wherein specific guidance and general consensus amongst scientific community does not exist.