FDA issued a guidance for industry entitled ‘‘Bioanalytical Method Validation.’’  This guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and provides the most up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.

To access the guidance go to https://www.fda.gov/downloads/Drugs/Guidance/ucm070107.pdf