Clinical Pharmacology Cases
Dosing Regimen Recommendation via Ethnic Sensitivity Analysis
For drugs developed simultaneously in China and the US, we utilize existing domestic and overseas healthy volunteer data, conduct ethnic sensitivity analysis combined with domestic Phase I clinical data, and propose an appropriate dosing regimen for Phase II clinical trials.
PK Bridging Study Application via Ethnic Sensitivity Analysis
For modified-release formulations, a PopPK model is built to determine optimal dosing regimens for Chinese subjects. Combined with ethnic sensitivity analysis, we support PK bridging study application and subsequent NDA submission.
Waive Phase I to Enter Phase II/III via Ethnic Sensitivity Analysis
For modified-release formulations with approved counterparts overseas, a PBPK model is applied to predict systemic and local in vivo exposure of the new formulation. With ethnic sensitivity analysis, we support applications to waive Phase I trials and directly initiate Phase II/III clinical trials.
