USFDA guidelines for bioanalytical method validation

This final 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.. Guidance for Industry Bioanalytical Method Validation Additional copies are available from: Office of Communications Division of Drug Information, WO51, Room 2201 Center for Drug Evaluation and Research Food and Drug Administration 10903 New Hampshire Ave., Silver Spring, MD 20993 Phone: 301-796-3400; Fax: 301-847-8714 [email protected]

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Bioanalytical Method Validation.". This final guidance incorporates public comments to the revised draft published in 2013 as well as the latest scientific feedback concerning bioanalytical method validation and.. The recently published final FDA Guidance [9] is a good step to create uniform rules for bioanalytical method validation. The more similar the documents are in the U.S. and Europe, the better it is for the global bioanalysis environment, both in the industry and in the academia.