Final guidance for industry entitled “Bioanalytical Method Validation” is provided by The Center for Drug Evaluation and Research and the Food and Drug Administration (FDA). 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 up-to-date information needed by drug developers to ensure the bioanalytical quality of their data.
The website is available here .
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