FDA has finalized bioanalytical validation guidance

June 18, 2018

The FDA has finalized guidance on validation of bioanalytical methods.   Differences between the draft and final guidance, which is 10 pages longer, include a re-working of the text, a new title for Section III, which was previously named “Chromatographic methods” but is now “Bioanalytical method development and validation,” and new sections on parameters of chromatographic assays (CCs) and ligand binding assays (LBAs).

“This final guidance incorporates public comments to the revised draft published in 2013 and provides recommendations for the development, validation, and in-study use of bioanalytical methods,” FDA said. “The recommendations can be modified with justification, depending on the specific type of bioanalytical method. This guidance reflects advances in science and technology related to validating bioanalytical methods.”