Interpretation and Application of the 2018 FDA Guidance on Bioanalytical Method Validation

Regulated bioanalysis (RBA) is required in the key parts of drug development that involve evaluations of drug safety, bioequivalence, and pharmacokinetics, and RBA data quality directly impacts the reliability of such assessments. RBA Method Validation requires compliance with various national method validation guidances, which will soon be superseded by harmonized guidance from the International Conference on Harmonisation (ICH). To ensure successful assay applications and regulatory submissions, bioanalytical methods are extensively evaluated and validated for accuracy/precision, selectivity, specificity, sensitivity, recovery, and stability under various operational conditions. Data generated for validation and sample analyses and all documentation necessary for reconstructing the validation study and sample analyses, (e.g. experimental data, protocols, reports, staff training records, SOPs, etc.) needs to be maintained and available for data audit and inspection.