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

Blog

Why the most important Phase 3 decisions should be made before Phase 3

Learn how advanced modeling for reimbursement strategy using MBMA and QSP strengthens payer evidence and…

CertaraMarch 24, 2026

Publication

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

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

Blog

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

Webinar

Building Trust in Data – Transparency, Traceability, and the Human Element

Danielle PillsburyMarch 5, 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

Blog

Rare disease day 2026: Accelerating rare disease drug development through cross-functional innovation

On Rare Disease Day 2026, Certara experts share how cross-functional innovation, regulatory strategies for rare…

CertaraFebruary 26, 2026

Blog

From documentation to design: Building a scalable metadata strategy for clinical research

Learn how clinical teams are treating metadata as infrastructure to improve reuse, auditability, and standards…

CertaraFebruary 26, 2026

Clinical Trials

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

Why the most important Phase 3 decisions should be made before Phase 3

Population Pharmacokinetic and Pharmacokinetic-Pharmacodynamic Analysis for Clazakizumab in Patients With End-Stage Kidney Disease Undergoing Dialysis

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

Regulatory horizons 2026: Clinical pharmacology strategy and regulatory expectations

Building Trust in Data – Transparency, Traceability, and the Human Element

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

Rare disease day 2026: Accelerating rare disease drug development through cross-functional innovation

From documentation to design: Building a scalable metadata strategy for clinical research

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