Final Guidance on Bioanalytical Method Validation - June 2018

  • By: Staff Editor
  • Date: June 12, 2018
  • Source:
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 On May 22, 2018, the US Food and Drug Administration (FDA) published a final guidance for industry entitled "Bioanalytical Method Validation.” This guidance incorporates public comments to the revised draft guidance that was issued in September 2013, and reflects advances in science and technology related to validating bioanalytical methods. 

The guidance addresses validating bioanalytical methods used in human clinical pharmacology, bioavailability, and bioequivalence studies that require pharmacokinetic, toxicokinetic, or biomarker concentration evaluation. It provides recommendations for the development, validation, and in-study use of bioanalytical methods. It applies to bioanalytical procedures such as chromatographic assays and ligand binding assays that quantitatively determine the levels of drugs, their metabolites, therapeutic proteins, and biomarkers in biological matrices such as blood, serum, plasma, urine, and tissue such as skin. The guidance can also inform the development of bioanalytical methods used for nonclinical studies that require toxicokinetic or biomarker concentration data. 

Validated analytical methods for the quantitative evaluation of analytes (i.e., drugs, including their metabolites) and biomarkers in a given biological matrix (e.g., blood, plasma, serum, or urine) are critical for the successful conduct of bioequivalence studies. For generic drug products, these validated methods provide critical data to support the bioequivalence of a proposed generic drug product to its reference listed drug.   

 The tables included in the guidance may help applicants with method development and validation and describe how to document the development and validation of a bioanalytical assay.

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