10 Strategic Foundations for Early Drug Development
探索有效的早期药物研发策略，从容而清晰地推进早期研发工作。Download…
Certara2025 年 11 月 26 日
The stepwise PIP is here to stay: From pilot flexibility to permanent EU regulation
The stepwise Paediatric Investigation Plan (PIP) is a strategic, flexible route for drug developers navigating…
Certara2025 年 11 月 26 日
The proposed food and drug administration (FDA) development safety update report (DSUR) guidance
Learn how FDA DSUR requirements reshape drug safety reporting, align with ICH E2F, and impact…
Certara2025 年 11 月 24 日
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
A Guide to the FDA Announcement to Phase Out Animal Testing for Drugs
FDA 正在逐步淘汰新药的动物实验。Learn how Certara’s Non-Animal Navigator™…
Certara2025 年 11 月 17 日
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
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
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
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
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
