Designing Drug Development Programs for Reimbursement Success
Download the guide to learn how model-informed drug development, QSP, and MBMA help align with…
Certara2026年5月7日
Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome
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…
Certara2026年5月7日
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…
Certara2026年5月7日
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,…
Certara2026年5月7日
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…
Certara2026年4月22日
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…
Certara2026年4月7日
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 Pillsbury2026年4月2日
6 ways Pinnacle 21 Enterprise centralized validation across studies
Learn how to centralize clinical data validation across studies using Pinnacle 21 Enterprise to improve…
Certara2026年4月1日
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…
Certara2026年3月25日
