Population Pharmacokinetic Modeling of Systemic Pharmacokinetic Data to Inform Bioequivalence in Regional Lung Exposure (U01) Clinical Trial Not Allowed
Department of Health and Human Services Food and Drug Administration
Posted on:
Type
Research/project funding
Reference Number
RFA-FD-23-017
Orally Inhaled Drug Products (OIDPs) are complex drug-device combination products. To establish bioequivalence for locally acting OIDPs, FDA is currently using a weight-of-evidence approach which generally includes a combination of in vitro BE studies; in vivo pharmacokinetic (PK) studies and comparative clinical endpoint (CCEP) or pharmacodynamic (PD) studies; along with formulation sameness and device similarity. For some OIDPs, both CCEP and PD studies can pose a challenge due to a lack of sensitivity to detect formulation differences. The purpose of this funding opportunity is to support research that will use modeling and simulation to investigate the feasibility of assessing formulation differences in regional lung exposure based on systemic PK concentration data to establish BE for OIDPs with different drug and product properties.
Categories: Consumer Protection, Science and Technology and other Research and Development.
Categories: Consumer Protection, Science and Technology and other Research and Development.