Publication

Population Pharmacokinetic Modeling of Niraparib to Assess Different Absorption Models

This publication describes the development of an updated population pharmacokinetic (PopPK) model for niraparib, a…

CertaraMay 21, 2026

Blog

Beyond approval: Using model-informed strategies to maximize the value of ADCs

Discover how model-informed drug development for ADCs integrates modeling, clinical data, and real-world evidence to…

CertaraApril 28, 2026

Blog

ADC dose optimization: Applying model-informed strategies in development

Explore ADC dose optimization using model-informed strategies to balance efficacy and safety across antibody drug…

CertaraApril 22, 2026

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

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

Adaptive clinical trials in oncology: Meeting the challenge of Project Optimus

Leveraging adaptive clinical trial designs in oncology can accelerate drug development, while following the FDA…

CertaraJanuary 16, 2026

Case Study

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Merck leveraged ADC modeling and pediatric ADC dose optimization to enable FDA acceptance and advance…

CertaraDecember 12, 2025

Blog

Using M&S to evaluate oncology drug dosing

Learn how modeling & simulation improves oncology drug dosing, optimizing safety, efficacy, and personalized treatment…

CertaraNovember 14, 2025

Case Study

Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Discover how MacroGenics optimized validation in their clinical data management with our centralized, collaborative Pinnacle…

CertaraNovember 12, 2025

Case Study

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

To accelerate the first oral therapy for hereditary angioedema (HAE), KalVista Pharmaceuticals partnered with Certara…

Danielle PillsburyNovember 12, 2025

Oncology/Hematology

Population Pharmacokinetic Modeling of Niraparib to Assess Different Absorption Models

Beyond approval: Using model-informed strategies to maximize the value of ADCs

ADC dose optimization: Applying model-informed strategies in development

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

ADC first-in-human (FIH) dose selection: Designing FIH studies for success

Adaptive clinical trials in oncology: Meeting the challenge of Project Optimus

Merck Advances Pediatric Oncology with Innovative ADC Modeling

Using M&S to evaluate oncology drug dosing

Validation in clinical data management: MacroGenics® Optimizes Validation and Issue Management with Pinnacle 21® Enterprise

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

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