Category: Posters

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Leveraging Real-World Evidence to Extend Drug-Drug Interaction Assessment from Drug Development to Clinical Care: A Targeted Review of the Literature

Presented at the ISPOR Europe, November 2024
Nadia Quignot, Nina Shigesi, Kazue Kikuchi, Sophie Argon, and Isabelle Ragueneau-Majlessi

2024 ISPOR Europe Poster Presentation – RWD DDI Reviews

Abstract

Evaluating DDIs in a real-world setting is key to accurately assess the clinical and economic outcomes of drugs. Real-World Data (RWD) can help in identifying potential DDIs, assessing their clinical significance, guiding dose adjustments to manage potential DDIs, and supporting overall benefit-risk assessment of drugs or drug combinations. This literature review aimed to characterize current applications of RWD in evaluating and mitigating DDI risks, while identifying gaps to be addressed.

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Mechanistic Studies Supporting the Evaluation of Pharmacokinetic-Drug Interactions with Drugs Approved by the U.S. Food and Drug Administration in 2023: a Systemic Review of New Drug Applications

Presented at the 26th North American ISSX and JSSX Meeting, September 2024
Jingjing Yu, Sophie Argon, Yan Wang, and Isabelle Ragueneau-Majlessi

2024 ISSX/JSSX Poster Presentation – 2023 NDA Reviews

Abstract

The mechanistic evaluation of enzyme- and transporter-based drug-drug interactions (DDIs) is an integral part of the drug development process and supports the safe and effective clinical use of new therapies. In the present work, DDI data for small molecular drugs approved by the U.S. Food and Drug Administration in 2023 (N = 38) were analyzed using the Certara Drug Interaction Database. The mechanism(s) and clinical magnitude of the observed interactions were characterized based on information available in the new drug application reviews.

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Risk of pharmacokinetic drug-drug interactions with novel drugs approved by the US FDA in 2022: a detailed review of DDI data from NDA documentation.

Presented at the 25th North American ISSX Meeting, September 2023
Jingjing Yu, Yan Wang, and Isabelle Ragueneau-Majlessi

2023 ISSX Poster Presentation – 2022 NDA Reviews

Abstract

Understanding the ADME processes involved in pharmacokinetic-based drug-drug interactions (DDIs) is critical to facilitate an optimal management of DDIs in the clinic. In the present work, drug metabolism and transport in vitro and in vivo data for small molecular drugs approved by the U.S. Food and Drug Administration in 2022 (N=22) were analyzed using the Certara Drug Interaction Database. The mechanism(s) and clinical relevance of these interactions were characterized based on information available in the new drug application (NDA) reviews.

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Understanding the role of CYP3A in the metabolism of kinase inhibitors marketed in the past decade to better manage the risk of clinical drug-drug interactions.

Presented at the 25th North American ISSX Meeting, September 2023
Jingjing Yu, Sophie Argon, Katie Owens, Ichiko Petrie, and Isabelle Ragueneau-Majlessi

2023 ISSX Poster Presentation – CYP3A-Kinase inhibitors

Abstract

Kinase inhibitors (KIs) are among the most represented therapeutic areas for novel drugs approved in recent years. In the present analysis, drug metabolism data for all KIs approved in the US since 2011 were reviewed. Mechanistic clinical drug interaction studies with CYP3A perpetrators were fully analyzed using Certara’s Drug Interaction Database (DIDB®). The mechanism(s) and clinical relevance of these interactions were characterized based on information available in the new drug application reviews.

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Enzyme- and Transporter-Mediated Clinical Drug Interactions with Drugs by the U.S. Food and Drug Administration in 2021: What Can be Learned from New Drug applications Reviews?

Presented at the ISSX/MDO Meeting, September 2022
Jingjing Yu, Yan Wang, and Isabelle Ragueneau-Majlessi

2022 ISSX Poster Presentation – 2021 NDA Reviews

Abstract

 The mechanistic evaluation of enzyme- and transporter-based drug-drug interactions (DDIs) during drug development is critical to support management strategies in the clinic.

The objectives of the study were to review pharmacokinetic-based clinical DDI data available in the new drug application (NDA) reviews for drugs approved by the FDA in 2021, and to understand the main mechanisms that mediate interactions resulting in label recommendations. 

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Systematic Review of Drug Disposition Characteristics of Drugs Most Affected by Hepatic Impairment

Presented virtually at 24th North American ISSX Meeting, September 2021
Jessica Sontheimer, Zoé Borgel, Jingjing Yu, William Copalu, Catherine K. Yeung, Eva Berglund, and Isabelle Ragueneau-Majlessi

2021 ISSX Poster Presentation – Drug Disposition Characteristics and Hepatic Impairment

Abstract

The aim of the study was to systematically review the disposition parameters of drugs most affected by hepatic impairment(HI) and investigate whether there are elimination characteristics (such as enzyme or transporter involvement in drug elimination) that predisposed for a large effect of HI on drug exposure.

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Anti-Infective Knowledgebase: Development of a Comprehensive Tool for Understanding the Disposition and the Interaction Potential of Anti-Infective Drugs Used in Low-Income Countries

Presented virtually at 24th North American ISSX Meeting, September 2021
Jingjing Yu,Yan Wang, Cheryl Wu, and Isabelle Ragueneau-Majlessi

2021 ISSX Poster Presentation – Anti-Infective Knowledgbase

Abstract

Patients with infectious diseases in low-income countries (LICs) are often at risk of pharmacokinetic (PK) drug-drug interactions (DDIs). To assist in silico mechanistic modeling and simulations to predict DDI liability and guide optimal management of DDIs, a knowledgebase of anti-infective drugs, specifically treatments for malaria and tuberculosis, has been established.

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Mechanisms and clinical significance of pharmacokinetic-based drug-drug interactions with drugs approved by the U.S. Food and Drug Administration in 2020

Presented virtually at the 24th North American ISSX Meeting, September 2021
Jingjing Yu, Yan Wang, and Isabelle Ragueneau-Majlessi

2021 ISSX Poster Presentation – 2020 NDA Clinical DDI Review

Abstract

The aim of the present work was to review pharmacokinetic drug-drug interaction (DDI) data available in New Drug Applications (NDAs) for drugs approved by the US Food and Drug Administration in 2020 and analyze the mechanisms mediating interactions in order to facilitate an optimal management of DDIs in the clinic.

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Exploring the Relationship of Drug BCS Classification, Food-Effect, and Gastric pH-Mediated Drug Interactions

Presented virtually at ASCPT Annual Meeting, March 2021
Katie Owens, Sophie Argon, Jingjing Yu, Isabelle Ragueneau-Majlessi, and colleagues at FDA

2021 ASCPT Poster Presentation – Drug BCS classification and absorption-based DDIs

Abstract

Food-effect (FE) and gastric pH-mediated drug-drug interactions (DDIs) are absorption-related. Here. we evaluated of the Biopharmaceutical Classification System (BCS) may be correlated with FE or pH-mediated DDI observed.

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Systemic Evaluation of Drug-Drug Interaction Labeling Language and Clinical Recommendations: Digoxin as an Example of Narrow Therapeutics Index P-Glycoprotein Substrate

Presented virtually at ASCPT Annual Meeting, March 2021
Lindsay M. Henderson, Claire Steinbronn, Jingjing Yu, Cathy Yeung, and Isabelle Ragueneau-Majlessi

2021 ASCPT Poster Presentation – DDI labeling language and clinical recommendations, digoxin as an example

Abstract

This study’s objective was to evaluate the consistency in DDI labeling language of recently marketed drugs (2012-2020) when found to alter the exposure of coadministered digoxin, a clinical P-glycoprotein (P-gp) substrate and narrow therapeutic index (NTI) medication.