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…CertaraJune 2, 2022
Simcyp Simulator Demonstrates Bioequivalence (BE), Eliminating Need for Costly Clinical Study Case Study 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…CertaraJuly 29, 2021
DDI Regulatory Poster Child using the Simcyp Simulator: Ibrutinib (Imbruvica®) Case Study 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…CertaraJuly 29, 2021