FDA Announces Availability of the Technical Specifications Guidance “Bioanalytical Methods Templates”

FDA Announces Availability of the Technical Specifications Guidance “Bioanalytical Methods Templates”

On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced the availability of a technical specifications guidance for industry entitled "Bioanalytical Methods Templates."

The "Bioanalytical Methods Templates" technical specifications guidance provides ready-to-use templates that sponsors can use to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation. The templates in this guidance are applicable to bioanalytical procedures such as chromatographic assays (CCs) and ligand-binding assays (LBAs) that quantitatively determine the levels of drugs and their metabolites and therapeutic proteins in biological matrices such as blood, serum, plasma, urine, and tissue such as skin.

The templates described in this guidance may be used for new drug applications (NDAs), biologics license applications (BLAs), and supplements to these applications to provide information regarding the bioanalytical methods for pharmacokinetic assessments. These detailed summary tables include bioanalytical method life cycle information, summary method performance, and summary of method modifications and cross-validation results. Inclusion of any additional bioanalytical information that might be relevant for the review of a submission is encouraged.

The "Bioanalytical Methods Templates" technical specifications guidance is available at https://go.usa.gov/xVsdJ and via the FDA Study Data Standards Resources website at https://go.usa.gov/xVsvR. Please refer to the final guidance for more details. General recommendations regarding bioanalytical method validation can be found in the May 2018 guidance entitled "Bioanalytical Method Validation" available at https://go.usa.gov/xVsdh and the June 2019 draft guidance entitled "M10 Bioanalytical Method Validation" available at https://go.usa.gov/xVsvc.