New Approach Methodologies (NAMs): By the numbers
We outline today’s animal-use landscape, the rise of NAMs, & how the Non-Animal Navigator supports…
Certara2025 年 12 月 10 日
Certara Cuts Pharmacometrics Submission Timelines in Half: New Expedited Service Accelerates Global Regulatory Filings
Certara launches an expedited Pharmacometrics (PMx) Regulatory Submission service that cuts submission timelines in half.
Certara2025 年 12 月 3 日
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
