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October 11, 2019

FDA Publishes Technical Specifications Guidance For Bioanalytical Methods Templates

Lynn L Bergeson

By Lynn L. Bergeson

On October 3, 2019, the U.S. Food and Drug Administration (FDA) announced that a technical guidance for industry titled “Bioanalytical Methods Templates” is now available.  The technical specifications guidance provides ready-to-use templates for sponsors to submit summaries of bioanalytical methods used in clinical pharmacology studies that require pharmacokinetic concentration evaluation.  The templates provided are applicable to bioanalytical procedures such as chromatographic assays (CC) and ligand-binding assays (LBA) 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 in this guidance can be used for new drug applications (NDA), biologics license applications (BLA), and supplements to these applications to provide information regarding bioanalytical methods for pharmacokinetic assessments.