FDAのmAbsに対する動物実験の段階的廃止に向けた準備と対策は万全ですか？
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
Learn how Certara helped ATHN standardize Real World Data for regulatory submissions, advancing rare disease…
Certara2025年4月8日
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…
Certara2025年1月30日
