Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform Publication Learn-confirm in model-informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics,…CertaraFebruary 10, 2025
EU CTIS: Europe’s New Clinical Trial Information System Blog EU CTIS: Europe’s New Clinical Trial Information System The EU CTIS is now fully implemented, replacing EudraCT as the central hub for clinical…CertaraFebruary 10, 2025
Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease Poster Simulations to Inform Dose Selection for a Phase 2b Trial Investigating TOUR006, a Fully Human Anti-IL6 Antibody, for Treatment of Thyroid Eye Disease CertaraFebruary 7, 2025
Measuring metabolites in index clinical DDI studies Blog Measuring metabolites in index clinical DDI studies February 7, 2025A key drug development safety consideration is whether the drug candidate will interact…CertaraFebruary 7, 2025
Machine Learning for Population PK Model Selection: Theory and Practice On-Demand Webinar Machine Learning for Population PK Model Selection: Theory and Practice Three of Certara's expert modelers provide a gentle introduction to machine learning in our field.…CertaraFebruary 7, 2025
Standards for All: Controlling Your Metadata for Vendors, Study Sites, and Submission Datasets On-Demand Webinar Standards for All: Controlling Your Metadata for Vendors, Study Sites, and Submission Datasets Director of Product, Certara's Pinnacle 21Senior Principal CDISC Consultant, Certara's Pinnacle 21Achieve submission ready conformance…CertaraFebruary 7, 2025
Simcyp Version 24: Advancing PBPK capabilities and translating new science and technology into regulatory-accepted predictive modeling On-Demand Webinar Simcyp Version 24: Advancing PBPK capabilities and translating new science and technology into regulatory-accepted predictive modeling With the release of Version 24, the Simcyp Simulator introduces cutting-edge enhancements that further elevate…CertaraFebruary 7, 2025
Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies Publication Population Pharmacokinetic and Pharmacodynamic Analysis of Navtemadlin in Patients with Relapsed and Refractory (R/R) Myelofibrosis (MF) and Other Myeloid or Solid Tumor Malignancies This study conducted a population pharmacokinetic (PK) and pharmacodynamic (PD) analysis of navtemadlin, an MDM2…CertaraFebruary 6, 2025
Behind the Science: Meet Pharmacometrics Expert Ahmed Abulfathi Video Behind the Science: Meet Pharmacometrics Expert Ahmed Abulfathi CertaraFebruary 5, 2025