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Optimizing DDI Knowledge throughout Drug Development

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CertaraJanuary 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,…

CertaraDecember 12, 2024

Publication

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

CertaraOctober 16, 2024

Video

Drug-Drug Interaction (DDI) Calculator

CertaraOctober 8, 2024

Conference

ISSX 27th North American Meeting

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CertaraSeptember 12, 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…

CertaraAugust 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…

CertaraJune 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.…

CertaraFebruary 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…

CertaraJune 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…

CertaraApril 11, 2022

Drug-Drug Interactions (DDI)

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

ISSX 27th North American Meeting

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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