BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs Webinar BioSpace webinar: Streamlining Nonclinical Development with FDA NAMs CertaraMay 8, 2026
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
Top 10 Benefits of Simcyp® Simulator for Drug Development Blog Top 10 Benefits of Simcyp® Simulator for Drug Development JTVCdGVhbV9qdW1wX2xpc3QlNUQ= April 23, 2026 Physiologically based pharmacokinetic (PBPK) modeling has evolved from an emerging methodology…CertaraApril 23, 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
Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations On-Demand Webinar Final ICH M15 Guidance: Aligning MIDD with Global Regulatory Expectations Watch this on-demand webinar to learn how the final ICH M15 guidance is shaping Model-Informed…CertaraApril 2, 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