Case Study

Model-Informed Development Accelerates Transformative Treatment for Sleeping Sickness

Certara’s drug development support enabled a positive scientific opinion from the EMA for acoziborole, a…

Certara2026年6月2日

ブログ

Rare disease day 2026: Accelerating rare disease drug development through cross-functional innovation

On Rare Disease Day 2026, Certara experts share how cross-functional innovation, regulatory strategies for rare…

Certara2026年2月26日

Press Coverage

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Explore how a collaborative “sandbox” approach—combining flexible regulation, data modeling, and stakeholder engagement—can transform rare…

Certara2026年1月30日

Blog

Certara’s Virtual Twin® QSP models: Transforming rare disease research into clinical insights

Certara’s Virtual Twin® QSP Models are transforming rare disease drug development, with real-world insights from…

Certara2025年11月25日

Publication

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Certara and Ionis analyzed Phase 3 OASIS-HAE data showing flexible, effective donidalorsen dosing can reduce…

Certara2025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

Move Away From Animal-Only Testing May Improve, Speed Rare Disease Research

The article, "Move Away From Animal-Only Testing May Improve, Speed Rare Disease Research," explores a…

Danielle Pillsbury2025年9月10日

Case Study

Optimizing Dosing and Regulatory Outcomes in Duchenne Muscular Dystrophy (DMD) Drug Development

Certara supported DMD drug development for Givinostat, helping Italfarmaco with pharmacometric and regulatory strategy.

Certara2025年7月29日

Press Coverage

Digital twins and virtual trials: A new era in rare disease drug development

Discover how using digital twins in rare disease drug development is improving precision and accelerating…

Certara2025年7月22日

White Paper

希少な腫瘍領域製品の上市の手引き：米国および欧州で成功するための普遍的な戦略

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Certara2025年2月28日

希少疾患および顧みられない疾患

Model-Informed Development Accelerates Transformative Treatment for Sleeping Sickness

Rare disease day 2026: Accelerating rare disease drug development through cross-functional innovation

Opinion: To Accelerate Rare Disease Progress, Take a Sandbox Approach

Certara’s Virtual Twin® QSP models: Transforming rare disease research into clinical insights

Exposure–Response Analysis of Donidalorsen for the Treatment of Hereditary Angioedema

Supporting Ionis’ Donidalorsen BLA with Biomarker HAE Attack Rate Modeling

Move Away From Animal-Only Testing May Improve, Speed Rare Disease Research

Optimizing Dosing and Regulatory Outcomes in Duchenne Muscular Dystrophy (DMD) Drug Development

Digital twins and virtual trials: A new era in rare disease drug development

希少な腫瘍領域製品の上市の手引き：米国および欧州で成功するための普遍的な戦略

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