||Recent Community Webinar
Regulatory Science Webinar
Title: PBPK Modeling and Clinical Evaluation of a Natural Product-Drug Interaction
Speaker: Mary Paine, RPh, PhD
Description: Natural products (NPs) such as botanical dietary supplements, fruit juices, and teas represent an ever-increasing share of the health care market. An estimated 20-30% of patients acknowledge taking NPs in conjunction with conventional medications, raising the risk of potential adverse NP-drug interactions. PBPK modeling and simulation of these complex interactions could be used to inform the necessity for clinical testing. Accurate models require a rigorous understanding of NP chemical make-up, knowledge of candidate precipitant NP constituents, robust parameters recovered from human-derived in vitro systems, and proof-of-concept clinical studies. This integrative approach was applied to an exemplar NP-drug combination. Further testing and refinement of this approach with additional NP-drug combinations will inform development of needed guidance for assessing the risk of NP-drug interactions.