Publication

尼拉帕利（Niraparib）群体药代动力学建模以评估不同吸收模型

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

Certara2026 年 5 月 21 日

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…

Certara2026 年 4 月 28 日

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…

Certara2026 年 4 月 22 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

ADC 首次人体（FIH）剂量选择：成功设计 FIH 研究的关键

Optimize ADC First-in-Human Dose Selection with model-informed strategies and exposure–response insights to design safer, more…

Certara2026 年 3 月 3 日

Blog

肿瘤精准剂量革命：Project Optimus下的适应性临床试验新范式

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

Certara2026 年 1 月 16 日

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…

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

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…

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

肿瘤学/血液学

尼拉帕利（Niraparib）群体药代动力学建模以评估不同吸收模型

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 首次人体（FIH）剂量选择：成功设计 FIH 研究的关键

肿瘤精准剂量革命：Project Optimus下的适应性临床试验新范式

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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