Waiving clinical studies & accelerating drug development for kinase inhibitor drugs
Whether you're in pre, early, or late clinical stages, this eBook offers real-world insights into…
CertaraAugust 28, 2024
PBPK Applications (MIFD) Using the Simcyp™ Simulator
Explores strategies, regulatory validation, and solutions in small-molecule human Physiologically Based Pharmacokinetic modeling (PBPK).
CertaraAugust 28, 2024
Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials
Asciminib (Scemblix®) is a novel drug with a unique mechanism of action for treating CML.…
CertaraAugust 27, 2024
Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator
The article "Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system…
CertaraAugust 26, 2024
A guide to developing population files for physiologically-based pharmacokinetic modeling in the Simcyp Simulator
This collaborative effort by Certara and the Centre for Applied Pharmacokinetic Research (CAPKR) at The…
CertaraJuly 24, 2024
ICH M12 Guidelines & Your Drug-Drug Interaction Package
We have provided an overview of the key changes to the ICH M12 drug-drug interaction…
CertaraJune 19, 2024
Attain FDA Label Claims for Kinase Inhibitor Drugs with the Simcyp™ Simulator
Simcyp was used by pharma and biotech companies to inform, reduce and/or replace clinical studies…
CertaraDecember 6, 2023
