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 PillsburyMarch 25, 2026

Blog

Interactive Global Value Dossiers: turning evidence into market access impact

Learn how an interactive global value dossier improves stakeholder engagement and streamlines value dossier preparation…

CertaraMarch 25, 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

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

Press Coverage Video

Building Smarter Trials With Bayesian Statistics

Learn how Bayesian statistics are transforming clinical trials with adaptive designs, faster insights, and more…

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

Fact Sheet

How to Improve CRO Data Management

Read this fact sheet to learn how Pinnacle 21 Enterprise improves CRO data management and…

CertaraMarch 23, 2026

On-Demand Webinar

Leveraging the full potential of PBPK models to accelerate drug development

Explore how Novartis applies PBPK modeling in drug development using Simcyp to support regulatory decisions,…

CertaraMarch 20, 2026

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

Interactive Global Value Dossiers: turning evidence into market access impact

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

Building Smarter Trials With Bayesian Statistics

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

How to Improve CRO Data Management

Leveraging the full potential of PBPK models to accelerate drug development

Newsletter sign up

Quick links

Solutions

Contact