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…
Danielle Pillsbury2025年4月14日
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…
Danielle Pillsbury2025年4月8日
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…
Danielle Pillsbury2025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…
Danielle Pillsbury2025年2月7日
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
