Certara Services Archives

Poster

Early Systematic PICO Scenario Identification and Prioritization for EU HTA Joint Clinical Assessments

Discover a systematic, AI-enabled approach to early PICO scenario identification and prioritization to improve EU…

Certara2025 年 11 月 20 日

Guide

A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs

The FDA is phasing out animal testing of new drugs. Learn how Certara’s Non-Animal Navigator™…

Certara2025 年 11 月 17 日

Blog

From Insight to Impact: Certainty EMEA 2025

See how GenAI, unified digital trials, and a Totality of Evidence approach transform regulatory docs,…

Certara2025 年 11 月 17 日

Blog

ACoP 2025 Insights: Scaling the Future of QSP Modeling with Certara IQ™

At ACoP 2025, Certara showcased innovation with the launch of Certara IQ™ and Phoenix® Cloud,…

Certara2025 年 11 月 13 日

On-Demand Webinar

Seeing Across Species: Empiric Pharmacokinetic Time-Course Scaling in Phoenix®

Watch our on-demand webinar on empiric PK time-course scaling and learn how Certara’s translational experts…

Certara2025 年 11 月 13 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

Announcement

Certara Study Shows Half of Americans Unaware of FDA/NIH Move to Phase Out Animal Testing of New Drugs

Certara’s new survey findings show that 50% of Americans are unaware of FDA and NIH…

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

Publication

Towards new approach methodologies for biological therapeutics: a novel model-informed metric to assess immunogenicity risk

Immunogenicity poses a significant challenge in biotherapeutics development due to the formation of anti-drug antibodies…

Danielle Pillsbury2025 年 11 月 7 日

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