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

Simcyp has led the way in the development and application of physiologically-based pharmacokinetics (PBPK) in drug development. From addressing safety issues such as drug-drug-interaction (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 Success Story Wheel Graphic

The Simcyp Simulator has informed dosing decision for 80+ new drugs and 250+ label claims for oncology, rare, CNS, cardiac, and other therapeutic areas. Simcyp enabled the first and only virtual bioequivalence approval for a complex generic drug.

Simcyp PBPK Simulator

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