PBPK, a Regulatory Necessity, Delivers ROI through Reduced R&D Cost and Time

Simcyp has led the way in the development and application of PBPK in drug development. From addressing safety issues such as DDI, to extrapolation of clinical outcomes in untested populations such as pediatric and organ impaired, Simcyp has delivered on its promise of expediting drug development for >20 years. Simcyp PBPK models describe the drug concentration in different organs, behavior across different body tissues, and thus help to inform clinical trial design, first-in-human dosing, formulation design, dose differentiation for special populations, and predictions related to potential DDIs. We will continue to share interesting case studies, which can be found here.

Simcyp Simulator 已为肿瘤、罕见疾病、中枢神经系统、心脏和其他治疗领域的 250 多个新药和 80 多个标签声明提供了给药决策。Simcyp 启用了第一个也是唯一的一种复杂仿制药的虚拟生物等效性批准。

Simcyp PBPK Simulator

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