Modeling and Simulation Archives

Publication

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

Publication

Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination

This study showcases how quantitative systems pharmacology (QSP) and model-informed drug development (MIDD) can transform…

Danielle Pillsbury2026 年 3 月 25 日

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…

Certara2026 年 3 月 25 日

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…

Certara2026 年 3 月 24 日

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 Pillsbury2026 年 3 月 24 日

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…

Certara2026 年 3 月 24 日

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…

Certara2026 年 3 月 24 日

Webinar

Pharmacometrics Under Pressure

Certara2026 年 3 月 20 日

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 -…

Certara2026 年 3 月 18 日

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…

Certara2026 年 3 月 11 日

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建模与模拟

An Integrated Nonclinical and Clinical Risk Assessment of the Effects of Investigational ATRi Tuvusertib on QTc Interval in Patients With Solid Tumors

Model-Based Patient Selection and Dosing Strategies for HRAS and PIK3CA Dysregulated HNSCC: A QSP Model for Alpelisib and Tipifarnib Combination

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

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

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