The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration eBook The Next Lap in Global Regulatory Submission Speed: Advanced Approaches to Excellence and Acceleration Discover advanced regulatory writing strategies, global regulatory submission best practices, eCTD guidance, ICH M15 updates…CertaraMarch 26, 2026
Portfolio Prioritization for Large and Small Pharma Using Early-Stage Biosimulation On-Demand Webinar Portfolio Prioritization for Large and Small Pharma Using Early-Stage Biosimulation Learn how early-stage biosimulation and mechanistic modeling enable smarter portfolio prioritization before IND-enabling studies. Watch…CertaraMarch 25, 2026
An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors Publication An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors This publication highlights how pharmacometric modeling, supported by Certara, was used to inform dose selection…CertaraMarch 25, 2026
Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination Publication Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination This study showcases how quantitative systems pharmacology (QSP) and model-informed drug development (MIDD) can transform…Danielle PillsburyMarch 25, 2026
Interactive Global Value Dossiers: turning evidence into market access impact Blog Interactive Global Value Dossiers: turning evidence into market access impact Learn how an interactive global value dossier improves stakeholder engagement and streamlines value dossier preparation…CertaraMarch 25, 2026
Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs) On-Demand Webinar Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs) Watch this on-demand webinar to learn how model-informed strategies using PopPK, PBPK, and QSP can…CertaraMarch 25, 2026
Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3 Blog Why the Most Important Phase 3 Decisions Should Be Made Before Phase 3 Learn how advanced modeling for reimbursement strategy using MBMA and QSP strengthens payer evidence and…CertaraMarch 24, 2026
Building Smarter Trials With Bayesian Statistics Press CoverageVideo Building Smarter Trials With Bayesian Statistics Learn how Bayesian statistics are transforming clinical trials with adaptive designs, faster insights, and more…CertaraMarch 24, 2026
Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis Publication Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis This study evaluated the pharmacokinetics (PK) and pharmacokinetic–pharmacodynamic (PK–PD) relationship of clazakizumab, an anti–interleukin-6 (IL-6)…Danielle PillsburyMarch 24, 2026
Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis Publication Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis This article describes how a model-informed drug development (MIDD) approach was used to support the…CertaraMarch 24, 2026