Physiologically Based Absorption and Pharmacokinetic Modeling and Simulation for Non-gastrointestinally Absorbed Drug Products In Humans

The objectives of this project are to develop, evaluate and improve physiologically based absorption and pharmacokinetic models for the following areas to support and facilitate generic drug guidance development, product development, and application review, in these areas. Subtopic 1: Physiologically based pharmacokinetic modeling and simulation of dermal absorption Subtopic 2: Physiologically based pharmacokinetic modeling and simulation of ocular absorption Subtopic 3: Physiologically based pharmacokinetic modeling and simulation for non-biological complex parenteral drug products (including liposomes, nanosuspension, micelles, microspheres, implants, and hydrogels) Subtopic 4: Physiologically based pharmacokinetic modeling and simulation of lung absorption via oral inhalation Subtopic 5: Physiologically based pharmacokinetic modeling and simulation of absorption from nasally delivered products (including nasal solutions, suspensions as well as nasal insufflation as a potential route of abuse) For each subtopic, the models should include but are not limited to formulation properties, drug substance properties, in vitro release mechanisms, physiology geometry, and microenvironment physiological parameters. The models should be based on the understanding of formulations, drug substance, physiology, mechanisms of drug delivery and mechanisms of drug transport. The final models should be able to predict drug concentration at the site of action, and drug plasma/blood concent...
Source: Grants.gov - Category: Research Tags: Health Science and Technology and other Research and Development Source Type: funding