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
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®)
Pharmacylics and J&J sought to bring ibrutinib, its new tyrosine kinase inhibitor therapy targeting rare…
Jim Gallagher2021年7月29日
