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

The Food and Drug Administration is seeking to advance non-invasive technologies capable of measuring how topically applied drugs penetrate and distribute within the skin in real time, with a focus on quantitative tomography-based methods. The goal is to develop accurate, sensitive, and reproducible tools that can characterize the rate and extent of drug availability at multiple depths within the skin, enabling repeated serial measurements over time to monitor cutaneous pharmacokinetics in vivo. This includes the creation of new apparatus, methodologies, study designs, and data analysis techniques specifically tailored to track drug concentration profiles in layers such as the epidermis, with the ultimate aim of establishing a scientifically valid in vivo approach to replace current methods for demonstrating bioequivalence between topical drug products. The funding opportunity, identified as a U01 clinical trial required award, is designed to support research that bridges the gap between existing pharmacokinetic models and practical regulatory applications for topical formulations. The successful applicant will be expected to produce a robust, standardized system capable of providing depth-resolved drug concentration data quickly and reliably across multiple time points. This technology has the potential to transform how topical products are evaluated for bioequivalence, reducing reliance on invasive sampling or indirect measures. All work must be conducted in vivo and should align with regulatory expectations, and applicants should be prepared to engage in active collaboration with the FDA, with Terrin Brown listed as the primary point of contact for grant-related inquiries.