Therapeutic Specialties Archives

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

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

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

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

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

Publication

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

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

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

Publication

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

This study used model-based meta-analysis (MBMA) to assess how well objective response rate (ORR) predicts…

Danielle PillsburyMarch 4, 2026

Blog

ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

CertaraMarch 3, 2026

Therapeutic Specialties

Population Pharmacodynamic Modeling of Plozasiran for Treatment of Familial Chylomicronemia Syndrome

Population Pharmacokinetics and Exposure-Response Analysis of Ziftomenib in Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation

Population Pharmacokinetic Modeling and Exposure-Response Analyses of Nemtabrutinib in Patients With Hematologic Malignancies

How Certara Enabled Fruquintinib FDA Approval for Metastatic Colorectal Cancer

Integrated Population Pharmacokinetic, Pharmacodynamic, and Safety Analyses to Inform Dosage Selection in the Clinical Development of the ATR Inhibitor Tuvusertib

Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

Right Dose, Right Regimen: Model-Informed Strategies for Antibody–Drug Conjugates (ADCs)

Model-informed drug development to support nemolizumab clinical development in adults and adolescents with moderate to severe atopic dermatitis

Model-Based Meta-Analysis of Objective Response Rate and Survival Endpoints to Compare PD-1 and PD-L1 Treatment Outcomes in Non-Small Cell Lung Cancer

ADC First-in-Human (FIH) Dose Selection: Designing FIH Studies for Success

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