Measuring metabolites in index clinical DDI studies
2025 年 2 月 7 日A key drug development safety consideration is whether the drug candidate will interact…
Danielle Pillsbury2025 年 2 月 7 日
Optimizing DDI Knowledge throughout Drug Development
Lorem ipsum dolor sit amet consectetur. Donec diam risus volutpat tempor. Massa accumsan aliquam nibh…
Danielle Pillsbury2025 年 1 月 6 日
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,…
Danielle Pillsbury2024 年 12 月 12 日
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…
Danielle Pillsbury2024 年 8 月 26 日
ICH M12 Guidelines & Your Drug-Drug Interaction Package
We have provided an overview of the key changes to the ICH M12 drug-drug interaction…
Danielle Pillsbury2024 年 6 月 19 日
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.…
Jim Gallagher2024 年 2 月 23 日
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…
Becca Bucci2022 年 6 月 2 日
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…
Jim Gallagher2022 年 4 月 11 日
