Asciminib – PBPK Modeling Streamlines Development and Avoids Over 10 Clinical Trials Case Study 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 Publication 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 Publication 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 Blog 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 Fact Sheet 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
Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy Case Study Using PBPK Models to Predict Effects of Hepatic Impairment & DDI in Olanzapine/Samidorphan Combination Therapy Olanzapine is an effective antipsychotic medication used to treat schizophrenia, a disease that affects about…CertaraOctober 31, 2022
Why you should select your drug formulation before starting clinical studies Blog Why you should select your drug formulation before starting clinical studies Drug developers often rush through the discovery process to get into human testing. Most are…CertaraOctober 28, 2022
Simcyp Discovery Simulator Brochure Simcyp Discovery Simulator Tailored for discovery and translational scientists, Simcyp Discovery Simulator is an intuitive software that delivers…CertaraJuly 14, 2022
Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease Case Study Simcyp Simulator Helps Optimize Drug Dosing in Adults & Adolescents with Orphan Disease Congenital adrenal hyperplasia (CAH) affects about 400,000 patients worldwide. Current therapy for CAH uses a…CertaraJune 6, 2022