M10 BIOANALYTICAL METHOD VALIDATION | FDA

M10 BIOANALYTICAL METHOD VALIDATION | FDA





FDA Announces Draft Guidance for Industry, "M10 Bioanalytical Method Validation”

The Food and Drug Administration (FDA) announced the availability of a draft guidance for industry, “M10 Bioanalytical Method Validation,” that was developed by the International Council for Harmonisation. The draft guidance describes the various elements and expectations to validate specific tests used to measure the parent and active metabolites of drugs administered in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.

The FDA is publishing this draft guidance to collect additional public comments. You may submit your comments to the draft guidance by September 25, 2019 to the docket (Docket No. FDA-2019-D-1469) available at https://www.regulations.gov. FDA and the International Council for Harmonisation M10 Expert Working Group will consider comments about this draft guidance.