Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Pharmacokinetic Tomography (U01 Clinical Trial Required)

The Food and Drug Administration (FDA) is seeking applications to support research and development of non-invasive technologies to characterize and compare the rate and extent of topically applied drugs in the skin. The goal is to develop an accurate, sensitive, and reproducible approach to measure the cutaneous pharmacokinetics of topical drug products. The funded work will focus on advancing pharmacokinetic tomography-based technologies, including apparatus, methods, study designs, and data analysis methods. The key aspects of this opportunity include: • Developing non-invasive technologies to measure cutaneous pharmacokinetics • Advancing pharmacokinetic tomography-based technologies • Supporting research and development of apparatus, methods, study designs, and data analysis methods • Focusing on topical drug products and their bioequivalence • Supporting the development of an alternative, scientifically valid, in vivo cutaneous PK-based approach