October 11, 2019
FDA Publishes Technical Specifications Guidance For Bioanalytical Methods Templates
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...