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…
CertaraMay 7, 2026
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
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
Explore ADC dose optimization using model-informed strategies to balance efficacy and safety across antibody drug…
CertaraApril 22, 2026
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
Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics
This review article examines the development of radiopharmaceutical imaging agents and radioligand therapies for pediatric…
CertaraMarch 26, 2026
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
This article describes how a model-informed drug development (MIDD) approach was used to support the…
CertaraMarch 24, 2026
Regulatory horizons 2026: clinical pharmacology strategy and regulatory expectations
Learn how regulatory expectations in clinical pharmacology are evolving and how to build a strategy…
CertaraMarch 24, 2026
