PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA Case Study PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…Becca Bucci2022 年 6 月 2 日
Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Case Study Simcyp™ Simulator 证明了生物等效性 (BE),无需进行昂贵的临床研究 In this case study, the sponsor’s closing of a manufacturing site required that one of…Jim Gallagher2021 年 7 月 29 日
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study 使用 Simcyp Simulator 的 DDI 监管典范案例:Ibrutinib (Imbruvica®) Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…Jim Gallagher2021 年 7 月 29 日