This repository presents an innovative method for the simultaneous estimation of in vivo fraction metabolized (fm) and gut bioavailability (FG) directly from clinical drug-drug interaction (DDI) study data. These methods have been rigorously evaluated using substrates that encompass a wide range of fm, FG, clearance, absorption, and distribution properties, utilizing both simulated and published clinical DDI study data (ref. lit.).
The novel methods described here are designed to enhance the robustness of DDI extrapolation and risk management in drug development. They also provide valuable insights for informing dose adjustment guidance in drug labels. These methods are intended to be used in conjunction with physiologically based pharmacokinetic (PBPK) modeling.
- DDI Extrapolation: Improve predictions of drug interactions in various clinical settings.
- Risk Management: Aid in the assessment and management of potential risks in drug development.
- Dose Adjustment Guidance: Inform recommendations for dose adjustments in drug labeling.
For more detailed information on the implementation and evaluation of these methods, please refer to the documentation and examples provided in this repository.
The link to run the app in a flexible way without having any R library installed locally.