Define.xml Submission Checklist Blog Post
Learn how to create a compliant Define.xml submission package with our Define.xml submission checklist, and best practice do’s and don’ts.
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
Click on any of the steps below to learn more.
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. In...
DMDG in vivo ADME one-day meeting 2024 Blog Post
How has the Inflation Reduction Act Impacted the Biosimilars Market? 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…
