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…

Certara2026年5月21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

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…

Certara2026年1月16日

Case Study

Merck、革新的なADCモデリングで小児がん領域の開発を推進

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

Certara2025年12月12日

Blog

Using M&S to Evaluate Oncology Drug Dosing

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

Certara2025年11月14日

Case Study

臨床データ管理におけるバリデーション：MacroGenics®、Pinnacle 21® Enterpriseでバリデーションと課題管理を最適化

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

Certara2025年11月12日

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 Pillsbury2025年11月12日

Case Study

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Discover how Certara applied exposure-response analysis and advanced modeling to optimize Donidalorsen dosing for hereditary…

Certara2025年11月10日

Press Coverage Video

Preparing for the Operational Burden of OS Requirements in Oncology Trials

Ananth Kadambi outlines how clinical operations teams can plan for FDA’s OS requirements—enhancing patient tracking…

Certara2025年9月26日

Press Coverage Video

How RWE and Predictive Modeling Support OS-Focused Trial Designs

Discover how real-world evidence and predictive modeling strengthen OS-focused trial designs in oncology, improving efficiency…

Certara2025年9月25日

腫瘍学／血液学

Population Pharmacokinetic Modeling of Niraparib to Assess Different Absorption Models

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

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

Merck、革新的なADCモデリングで小児がん領域の開発を推進

Using M&S to Evaluate Oncology Drug Dosing

臨床データ管理におけるバリデーション：MacroGenics®、Pinnacle 21® Enterpriseでバリデーションと課題管理を最適化

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Preparing for the Operational Burden of OS Requirements in Oncology Trials

How RWE and Predictive Modeling Support OS-Focused Trial Designs

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