Principal Investigator (PI): De Fang OUYANG, Associate Professor
Year: 2024
“MIDD strengthens the scientific and empirical foundation in the drug development process within Pharmaceutical Regulatory Science, contributing to ensuring the safety, efficacy, and rational use of new drugs and improved drug formulations.”
Regulatory Science Challenge
Formulation improvement is an effective means to broaden drug indications and target populations, reducing development costs for repurposing existing drugs and accelerating patient benefit time. In the process of improving drug formulations, in vivo evaluation of drug-modified formulations is characterized by high cost and time consumption.
Model-informed Drug Discovery and Development (MIDD) plays a role in accelerating drug approval and exploring drug data. In the regulatory approval process, application of models provides a basis for subsequent model-informed decisions on drug formulation improvement, regulating the drug development, approval, and market supervision process of improved drug formulations. Based on mathematical models and simulation techniques, application of models helps optimize drug formulation design and dose selection, thereby increasing trial success rates and reducing development costs in the drug development process. MIDD integrates and analyzes clinical and preclinical data in drug development, ultimately advances the approval process for these formulations. To conclude, MIDD strengthens the scientific and empirical foundation in the drug development process within Pharmaceutical Regulatory Science, contributing to ensuring the safety, efficacy, and rational use of new drugs and improved drug formulations.
Project Description
This research project aims to mechanistically describe the pharmacokinetic behavior of a new formulation of dipyridamole in the pediatric population based on modeling and simulation techniques. This is to support the dosage improvement and dose selection, accelerating the success rate of drug development and reducing drug development costs. In drug development and regulatory approval processes, this project integrates preclinical and clinical data and uses the physiological-based pharmacokinetic modeling (PBPK), to conduct risk assessment, in vivo evaluation, and scenario simulation for the new dipyridamole formulation to determine its risks and benefits, to advance the approval process, and to provide a basis for the approval of new drug formulations. This study is intended to support the optimization of poorly soluble drug formulations, strengthening the scientific foundation in the drug development process to ensure the safety, efficacy, and rational use of new drugs and improved drug formulations.
