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
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
Drug developers often rush through the discovery process to get into human testing. Most are…
CertaraOctober 28, 2022
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
Congenital adrenal hyperplasia (CAH) affects about 400,000 patients worldwide. Current therapy for CAH uses a…
CertaraJune 6, 2022
PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA
In 2020, the US FDA approved Risdiplam (Evrysdi®) as the first orally administered drug to…
CertaraJune 2, 2022
