Drug-Drug Interactions (DDI) Archives

Blog

Measuring metabolites in index clinical DDI studies

February 7, 2025A key drug development safety consideration is whether the drug candidate will interact…

Danielle PillsburyFebruary 7, 2025

On-Demand Webinar

Optimizing DDI Knowledge throughout Drug Development

Lorem ipsum dolor sit amet consectetur. Donec diam risus volutpat tempor. Massa accumsan aliquam nibh…

Danielle PillsburyJanuary 6, 2025

Publication

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 PillsburyDecember 12, 2024

Publication

Medicines in pregnancy: A clinical pharmacology extrapolation framework to address knowledge gaps

Danielle PillsburyOctober 16, 2024

Video

Drug-Drug Interaction (DDI) Calculator

Danielle PillsburyOctober 8, 2024

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…

Danielle PillsburyAugust 26, 2024

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…

Danielle PillsburyJune 19, 2024

Publication

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 GallagherFebruary 23, 2024

Case Study

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 BucciJune 2, 2022

Case Study

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 GallagherApril 11, 2022

Drug-Drug Interactions (DDI)

Measuring metabolites in index clinical DDI studies

Optimizing DDI Knowledge throughout Drug Development

Static Versus Dynamic Model Predictions of Competitive Inhibitory Metabolic Drug–Drug Interactions via Cytochromes P450: One Step Forward and Two Steps Backwards

Medicines in pregnancy: A clinical pharmacology extrapolation framework to address knowledge gaps

Drug-Drug Interaction (DDI) Calculator

Prediction of CYP-mediated DDIs involving inhibition: Approaches to address the requirements for system qualification of the Simcyp Simulator

ICH M12 Guidelines & Your Drug-Drug Interaction Package

Guide to development of compound files for PBPK modeling in the Simcyp population-based simulator

PBPK Modeling in Adults Enables DDI Risk Assessment in Children with SMA

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

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