The specific aims of this research include comparing in vivo cutaneous pharmacokinetic (PK) measurements by independent techniques such as dermal open flow microperfusion (dOFM), dermal microdialysis (dMD), or spectroscopic tomography; exploring the removal of the topical formulations at different time points and characterizing the resulting PK profiles of the test product and the reference standard; developing data analysis techniques; and identifying appropriate PK endpoints for the evaluation of topical BE. The outcomes of this research are expected to help US Food and Drug Administration (US-FDA) improve the efficiency of current BE approaches for topical generic products with compositional differences relative to the reference standard.
- Read more about Optimized Clinical Dermal Open Flow Microperfusion Study Design to Demonstrate Bioequivalence Based on Cutaneous Pharmacokinetics here
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD007669 totaling $1,500,000 funded by FDA/HHS. The contents are those of the authors and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.