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25May18

New FDA Guidance on Bioanalytical Method Validation

The FDA has issued a Guidance for Industry entitled “Bioanalytical Method Validation”. This guidance replaces the draft guidance that was issued in September 2013, and reflects advances in science and technology validating bioanalytical methods. 

Bioanalytical methods provide critical data to support the safety and efficacy of drugs and biologic products. The final guidance describes the elements of bioanalytical method development and validation for chromatographic or ligand binding assays that are needed to ensure the quality and the reliability of the PK and biomarker data it generates and describes how to evaluate new analytical technologies, and how to assess validation of dried blood spot sampling and commercial kits that are re-purposed for drug development. Reference tables included in the guidance may help sponsors with method validation and study report documentation to support FDA drug application.

The final guidance can be located here: Bioanalytical Method Validation.

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