【摘 要】
：
Prediction of human PK at the preclinical stage can aid: ① human efficacious dose prediction, ②) human safety risk assessment based on detailed pharmacoki
【机 构】
：
Millennium, Takeda, Cambridge USA
【出 处】
：
2015年第一届药代动力学朝阳论坛
论文部分内容阅读
Prediction of human PK at the preclinical stage can aid: ① human efficacious dose prediction, ②) human safety risk assessment based on detailed pharmacokinetic information such as the maximum concentration (Cmax), total exposure (AUC) at steady state, and elimination rate (t1/2).It can also assist CMC in optimizing the formulation and initial API need in the early clinical trial and manufacturing scale decision.In this presentation, PBPK modeling will be discussed for prediction of human PK at the drug discovery stage using preclinical data.Commercially available software, such as Simcyp and GastroPlus will be compared against each other.
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