Bioanalytical Method Validation Guidance

https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm070107.pdf


On May 22, 2018, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry entitled “Bioanalytical Method Validation”, which reflects advances in science and technology for validating bioanalytical methods. This guidance addresses validating bioanalytical methods used in nonclinical and 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, 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 biologic products, and their metabolites) and biomarkers in a given biological matrix (e.g., blood, plasma, serum, or urine) are critical for the successful conduct of nonclinical, biopharmaceutics, and clinical pharmacology studies. These validated methods provide critical data to support the safety and effectiveness of drugs and biologic products. Validating the analytical method ensures that the data are reliable by evaluating certain key questions relative to the stage of drug development including:

• Does the method measure the intended analyte?  
• What is the variability associated with these measurements?
• What is the range in measurements that provide reliable data?  
• How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method?  

The “Bioanalytical Method Validation” guidance is available at https://go.usa.gov/xQmrk. Please refer to the guidance for more details.

Instructions for submitting either electronic or written comments on Agency guidances at any time may be found in the federal register notice for this guidance (https://go.usa.gov/xQmCb).