FDA Announces Draft Guidance for Bioanalytical Method Validation

FDA announced the availability of a draft guidance for industry, “M10 Bioanalytical Method Validation,” in a June 28, 2019 press release. The draft guidance, developed by the International Council for Harmonization (ICH), is intended to provide recommendations for the validation of bioanalytical assays for chemical and biological drug quantification and their application in the analysis of study samples.

The guidance describes the various elements and expectations to validate specific tests used to measure the parent and active metabolites of drugs administered in nonclinical and clinical studies submitted in regulatory applications for biological matrices such as plasma, blood, or serum.

FDA is publishing this draft guidance to collect additional public comments. Comments can be submitted by September 25, 2019 to the docket (Docket No. FDA-2019-D-1469) available at www.regulations.gov. FDA and the ICH M10 Expert Working Group will consider comments about this draft guidance.