Physiologically Based Pharmacokinetic Model for Nose-to-Brain Drug Delivery (U01) Clinical Trial Optional

Nasal drug products are typically designed to target either local or systemic pharmacokinetics (PK) following deposition of the inhaled aerosol. However, an emerging target for nasal drug product development is nose-to-brain delivery via a variety of pathways in the nasal cavity. Physiologically based pharmacokinetic (PBPK) models have previously been developed by several groups for a variety of reasons related to toxicology and drug delivery. However, currently available nasal PBPK models do not include pathways for nose-to-brain drug delivery. The purpose of this funding opportunity is to fund the development of a nasal PBPK model that includes at least one pathway for nose-to-brain drug delivery and links with a full body PBPK model that includes, at least, a brain compartment. It is expected that the model will rely on experimental data as much as possible, where experimental studies may need to be included in the proposal to support model development. Once the model has been developed, it is expected that PK predictions will be produced for a preselected target compound.