Designing Drug Development Programs for Reimbursement Success Guide Designing Drug Development Programs for Reimbursement Success Download the guide to learn how model-informed drug development, QSP, and MBMA help align with…CertaraMay 7, 2026
Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome Publication Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome A newly approved RNA interference (RNAi) therapy lowers harmful triglyceride (TG) levels in patients with…CertaraMay 7, 2026
Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation Publication Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation This study evaluated how the leukemia drug ziftomenib behaves in the body and whether different…CertaraMay 7, 2026
Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies Publication Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies Population pharmacokinetic (PopPK) and exposure-response modeling were used to support the clinical development of nemtabrutinib,…CertaraMay 7, 2026
ADC dose optimization: Applying model-informed strategies in development Blog ADC dose optimization: Applying model-informed strategies in development Explore ADC dose optimization using model-informed strategies to balance efficacy and safety across antibody drug…CertaraApril 22, 2026
How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer Case Study How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer HUTCHMED was preparing a New Drug Application (NDA) submission for FRUZAQLA® (fruquintinib) a drug developed…CertaraApril 7, 2026
Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib Publication Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib This study demonstrates how a model-informed, totality-of-evidence approach was used to select the optimal clinical…Danielle PillsburyApril 2, 2026
6 ways Pinnacle 21 Enterprise centralized validation across studies Infographic 6 ways Pinnacle 21 Enterprise centralized validation across studies Learn how to centralize clinical data validation across studies using Pinnacle 21 Enterprise to improve…CertaraApril 1, 2026
Pinnacle 21 Community vs Enterprise: Watch the webinar to decide what’s right for your study On-Demand Webinar Pinnacle 21 Community vs Enterprise: Watch the webinar to decide what’s right for your study Watch the Pinnacle 21 Community vs Enterprise webinar to learn key considerations for validation approaches…CertaraMarch 27, 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