Modeling and Simulation Archives

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

Pharmacometrics Under Pressure

CertaraMarch 20, 2026

Blog

ICH M15 Guideline: What the Finalized Guideline Means for Model-Informed Drug Development

With the release of the draft ICH M15 guidance, MIDD is no longer optional -…

CertaraMarch 18, 2026

Blog

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

Explore how model-informed drug development and AI are advancing pharmacoequity and shaping the future of…

CertaraMarch 11, 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

Conference

Apotekarsocieteten Clinical Pharmacology Strategies in Drug Development

Danielle PillsburyMarch 2, 2026

Blog

Embracing Model-Informed Drug Discovery: The Path to Better Clinical Outcomes

We cover the evidence of biosimulation improving clinical success rates, making the case for model-informed…

CertaraFebruary 27, 2026

Modeling and Simulation

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

Pharmacometrics Under Pressure

ICH M15 Guideline: What the Finalized Guideline Means for Model-Informed Drug Development

Advancing pharmacoequity through model-informed drug development: Insights from ASCPT 2026

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

Apotekarsocieteten Clinical Pharmacology Strategies in Drug Development

Embracing Model-Informed Drug Discovery: The Path to Better Clinical Outcomes

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