FDA Finalizes Guidance on Bioanalytical Method Validation

The FDA has released a final guidance document intended to help industry members develop bioanalytical methods and validations that are required by the FDA to ensure the quality of an assay and the reliability of the data it generates.

The guidance incorporates public comments to the revised draft guidance that was first published in 2013. It also provides recommendations for the development, validation, and in-study use of bioanalytical methods.

The guidance indicates that its recommendations can be modified with justification, depending on the specific type of bioanalytical method.

In order to validate the analytical method used to evaluate analytes (for example, drugs, including biologics, and their metabolites), the FDA recommends that if the data address the following key questions, they are reliable:

• Does the method measure the intended analyte, and is it specific or selective?
• Is there variability associated with these measurements? What is the accuracy and precision of the method?
• What is the sensitivity of the method (ie, what is the lower limit of quantitation and the upper limit of quantitation)?
• How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method?

Additionally, the final guidance incorporates a new title for Section 3, “Bioanalytical Method Development and Validation,” as well as new sections about the bioanalytical parameters that apply to chromatographic assays and ligand binding assays.

Specifically, the guidance has included the latest scientific practices in method validation, newer science on incurred sample reanalysis, the use of new analytical platform, the repurposing of diagnostic kits for drug development, and validation for biomarkers in drug development.