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

さらに、悪性腫瘍、希少疾患、中枢神経疾患、心疾患を含めた様々な治療領域の 80 件以上の新薬承認申請や 250 件以上の医薬品添付文書に対する用量選択の意思決定を支援し、近年では、バーチャルの生物学的同等性の立証による複雑な後発医薬品の承認取得の実現にも貢献しています。

Simcyp PBPK Simulator


Powered by Translations.com GlobalLink OneLink Software