Optimizing DDI Knowledge throughout Drug Development
Lorem ipsum dolor sit amet consectetur. Donec diam risus volutpat tempor. Massa accumsan aliquam nibh…
CertaraJanuary 6, 2025
Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards
Predicting metabolic drug–drug interactions (DDIs) via cytochrome P450 enzymes (CYP) is essential in drug development,…
CertaraDecember 12, 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
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
Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator
The Simcyp Simulator is a software platform for population physiologically-based pharmacokinetic (PBPK) modeling and simulation.…
CertaraFebruary 23, 2024
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
PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials
Genentech was developing polatuzumab vedotin (Polivy), an anti-CD79b-vc-monomethyl auristatin E (MMAE) antibody-drug conjugate (ADC) to…
CertaraApril 11, 2022
