FDA Announces Availability of the Draft Guidance, “M10 Bioanalytical Method Validation”

On June 27, 2019, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “M10 Bioanalytical Method Validation.” The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH) and is intended to provide industry with the regulatory expectations for bioanalytical method validation of assays used to support regulatory submissions. ICH was established to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives.

The “M10 Bioanalytical Method Validation” draft guidance describes the method validation expectations for bioanalytical assays for nonclinical and clinical studies that generate data to support regulatory submissions. It is applicable to the validation of bioanalytical methods used to measure concentrations of chemical and biological drug(s) and their metabolite(s) in biological samples obtained in pivotal nonclinical toxicokinetic (TK)/pharmacokinetic (PK) studies that are used to make regulatory decisions and all phases of clinical trials in regulatory submissions. The draft guidance also applies to the quantitative analysis by ligand binding assays (LBAs) and chromatographic methods such as liquid chromatography (LC) or gas chromatography (GC), which are typically used in combination with mass spectrometry (MS) detection and occasionally with other detectors.

Concentration measurements of chemical and biological drug(s) and their metabolite(s) in biological matrices are an important aspect of drug development. The results of pivotal nonclinical TK/PK studies and of clinical trials, including comparative bioavailability/bioequivalence (BA/BE) studies, are used to make regulatory decisions regarding the safety and efficacy of drug products. It is therefore critical that the bioanalytical methods used are well characterised, appropriately validated and documented in order to ensure reliable data to support regulatory decisions.

FDA is publishing this draft guidance to collect additional public comments. You may submit your comments to the draft guidance by September 25, 2019 to the docket (Docket No. 2019-13698) available at https://www.regulations.gov. Your comments do make a difference and can impact the outcomes of FDA regulatory policy. Share your knowledge and experience, and make your voice count.

The “M10 Bioanalytical Method Validation” draft guidance is available at https://go.usa.gov/xyYvm.  Please refer to the guidance for more details.

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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.