您是否已为 FDA 逐步淘汰单抗（mAbs）动物试验做好准备？
Senior Vice President, Certara Drug Development Solutions Fran has over 25 years of experience with…
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How Certara MIDD Experts Overcame Client Regulatory Challenges
Certara’s Model-Informed Drug Development (MIDD) approach leverages an integrated, quantitative systems methodology to accelerate regulatory…
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Standardizing Real World Data in Rare Disease: ATHN’s Journey
The American Thrombosis and Hemostasis Network (ATHN), a not-for-profit organization, has been improving care and…
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Streamline Clinical Data Publication Under EMA Policy 0070
2025 年 2 月 14 日 The European Medicines Agency (EMA) Policy 0070 requires clinical data publication. Its…
Certara2025 年 2 月 14 日
Simcyp Version 24: Advancing PBPK capabilities and translating new science and technology into regulatory-accepted predictive modeling
With the release of Version 24, the Simcyp Simulator introduces cutting-edge enhancements that further elevate…
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How to Validate Your Clinical Data Using FDA Validation Rules
2025 年 1 月 30 日 For clinical data managers, understanding clinical data validation and applying FDA validation…
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