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

On-Demand Webinar

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

In today’s market where long development timelines and investor caution can slow progress, MIDD offers…

Certara2025 年 11 月 10 日

Guide

降低药物设计风险：早期可行性评估如何改变生物治疗药物的研发

Learn how Early Feasibility Assessment and QSP modeling improve drug design, de-risk feasibility studies, &…

Certara2025 年 11 月 7 日

Publication

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

This study demonstrates how model-informed approaches can improve dose selection decisions when direct clinical comparisons…

Certara2025 年 11 月 5 日

On-Demand Webinar

按时交付：借助定量药理学分析洞见，顺利推进监管申报

Watch this on-demand webinar to learn how pharmacometrics supports NDA, BLA, and global regulatory submissions.…

Certara2025 年 11 月 3 日

Publication

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Bridge across studies with Model-based Meta Analysis, incorporating broader data & synthetic patients to enhance…

Certara2025 年 10 月 31 日

Blog

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Applying NCA and PopPK to ADCs helps decode complex PK, balance DAR effects, and guide…

Certara2025 年 10 月 24 日

Blog

Bottlenecks to Breakthroughs: Tackling Challenges in QSP Modeling

QSP modeling holds huge promise, but complexity and scalability limit adoption. We review the challenges…

Certara2025 年 10 月 22 日

On-Demand Webinar

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

Learn how model-informed drug development, clinical pharmacology, and regulatory strategy support successful pediatric drug development…

Certara2025 年 10 月 21 日

模型引导的药物开发

Supporting KalVista’s NDA Submission for a Novel HAE Treatment

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Model-Informed Drug Development (MIDD) as a tool to Enhance Asset Value and Address Key Investor Concerns

降低药物设计风险：早期可行性评估如何改变生物治疗药物的研发

Quantitative Model-Informed Dose Selection for a Milvexian Phase III Study in Patients With Atrial Fibrillation

按时交付：借助定量药理学分析洞见，顺利推进监管申报

Establishing Immune Correlates of Protection Against Respiratory Syncytial Virus Infection to Accelerate Vaccine Development: A Model-Based Meta-Analysis

Key Lessons & Opportunities in applying NCA and PopPK to ADCs

Bottlenecks to Breakthroughs: Tackling Challenges in QSP Modeling

AAPS Webinar – Pediatric Drug Development: Why It’s Critical to Submission Strategy and How Modeling, Regulatory, and Clinical Insights Shape Success

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