Publication

A glimpse into the future of model-informed drug discovery and development

Explore the future of Model-Informed Drug Development (MIDD), including advances in pharmacometrics, PBPK, QSP, precision…

CertaraAugust 28, 2026

Publication

Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology

Explore how model-based tumor growth inhibition metrics can support earlier Go/No-Go decisions and pivotal trial…

CertaraAugust 28, 2026

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

Oncology/Hematology

A glimpse into the future of model-informed drug discovery and development

Refinement of Operating Characteristics for Model-Based TGI Metrics Decision Support to Ungate a Pivotal Trial in Oncology

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

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