Bioequivalence of Topical Products: Elucidating Fundamental Principles of Dermal Pharmacokinetics for Microdialysis or Microperfusion Techniques (U01) Clinical Trials Not Allowed

The purpose of this funding opportunity is to elucidate how pharmacokinetic principles and concepts (e.g., dose, fraction of drug absorbed, apparent volume of distribution, Cmax, AUCinfinity) should be applied or adapted when evaluating the rate and extent to which a topically applied compound becomes available in the dermis, at or near a site of action within the skin, and to evaluate the relative sensitivity of in vivo dermal pharmacokinetic methods to discriminate differences in drug concentrations in the skin. The expectation is that the funded work will establish appropriate designs and analyses for in vivo dermal microdialysis (dMD) or dermal open flow microperfusion (dOFM) studies to evaluate topical bioavailability and bioequivalence based upon appropriate dermal pharmacokinetic endpoints.