Define.xml Submission Checklist Blog Post
通过我们的 Define.xml 申报检查清单与最佳实践要点与禁忌，学习如何创建合规的 Define.xml 申报包。
EUROTOX 2024 Blog Post
Waiving clinical studies & accelerating drug development for kinase inhibitor drugs Blog Post
Whether you’re in pre, early, or late clinical stages, this eBook offers real-world insights into the power of PBPK modeling.
PBPK Applications (MIFD) Using the Simcyp™ Simulator Blog Post
Explores strategies, regulatory validation, and solutions in small-molecule human Physiologically Based Pharmacokinetic modeling (PBPK).
Certara’s Integrated, Compliant Clinical Data Solution From Trial to Regulatory Submission Blog Post
点击以下任一步骤，了解更多信息。
Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials Blog Post
Asciminib (Scemblix®) is a novel drug with a unique mechanism of action for treating CML. It specifically targets the BCR-ABL tyrosine kinase, offering a targeted approach to the disease. {{N:1}}...
DMDG in vivo ADME one-day meeting 2024 Blog Post
《降低通胀法案》对生物类似药市场有何影响？ Blog Post
The Inflation Reduction Act (IRA), one of the key legislative achievements the Biden-Harris administration, aims to expand benefits and reduce costs for Medicare beneficiaries. Among its provisions, the IRA introduced…
Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator Blog Post
The article “Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator” by Kilford et al. outlines a framework for qualifying the…
The Uncertain Path Forward for Psychedelic Medicine Blog Post
Certara’s Dr. Fran Brown, Senior Vice President of Drug Development Science, is quoted in this WIRED article about the FDA’s recent rejection of Lykos Therapeutics’ proposed MDMA treatment for post-traumatic…
