[規範更新] FDA新指引草案：基於定量系統藥理學與體外數據評估首次人體試驗起始劑量

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-systems-pharmacology-qsp-based-dose-selection-minimum-anticipated-biological-effect


https://www.fda.gov/media/193230/download