Modeling & Simulation Cases
PopPK/PD Model to Support Phase II Waiver
Different from the conventional Phase I→II→III→NDA development route, population PK/PD analysis built on existing clinical data can be submitted to waive Phase II trials and directly advance to Phase III studies.
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PBPK-DDI Model for DDI Clinical Study Exemption
With data of strong CYP inhibitors/inducers, PBPK-DDI simulation predicts DDI risk of moderate/weak modulators, which can be used to apply for exemption of dedicated clinical DDI trials.
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Mechanism-Based PK/PD for Direct Phase III Without Phase II
Proton pump inhibitors have well-defined pharmacological mechanisms. Intragastric pH as PD biomarker correlates closely with clinical endpoints. Mechanism-driven PK/PD models are applied to screen optimal clinical regimens and support Phase II waiver applications.
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PopPK Model for Dosing Regimen Optimization
For modified-release formulations, integrate PK profiles of multiple dosage forms, build PopPK model, identify covariates such as body weight and gender, optimize clinical dosing regimens for NDA submission.
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PBPK Model for FIH Starting Dose Recommendation
Leverage reference drugs with similar pharmacology, construct PBPK model to extrapolate human PK from preclinical animal data, predict minimal effective dose and maximum tolerated dose for First-in-Human trials.
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AI-PBPK Coupled P-CAB PK/PD Model
Predict ADME parameters from molecular structure, combine in vitro P-CAB proton inhibition data, build PBPK-PD model to simulate intragastric pH curves, realize early human PK/PD assessment at preclinical stage.
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Dosing Regimen Recommendation via Ethnic Sensitivity Analysis
For drugs developed simultaneously in China and the US, based on existing healthy subject data from both regions, conduct ethnic sensitivity analysis combined with domestic Phase I data to recommend optimal dosing regimens for Phase II trials.
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PK Bridging Study Application via Ethnic Sensitivity Analysis
For modified-release formulations, establish a PopPK model to screen dosing regimens for Chinese population. Combined with ethnic sensitivity analysis, apply for NDA through PK bridging studies.
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Phase I Waiver for Direct Phase II/III via Ethnic Sensitivity Analysis
For modified-release formulations with approved overseas new dosage forms, construct a PBPK model to predict systemic and local exposure, conduct ethnic sensitivity analysis, and apply for waiver of Phase I studies.
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