News

 |  Publications
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Analysis of Drug-Drug Interaction Labeling Language and Clinical Recommendations for Newly approved Drugs Evaluated With Digoxin, Midazolam, and S-Warfarin

Clin Ther. 2021 Nov;43(11):2032-2039

Abstract

To best promote drug tolerability and efficacy in the clinic, data from drug-drug interaction (DDI) evaluations and subsequent translation of the results to DDI prevention and/or management strategies must be incorporated into the US Food and Drug Administration (FDA) product labeling in a consistent manner because differences in language might result in varied interpretations. This analysis aimed to assess the consistency in DDI labeling language in New Drug Applications (NDAs).

 |  Posters
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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.

 |  Posters
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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.

 |  Posters
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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.

 |  Publications
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Excipient knowledgebase: Development of a comprehensive tool for understanding the disposition and interaction potential of common excipients

CPT Pharmacometrics Syst Pharmacol. 2021 Aug;10(8):953-961

Abstract

Although the use of excipients is widespread, a thorough understanding of the drug interaction potential of these compounds remains a frequent topic of current research. Not only can excipients alter the disposition of coformulated drugs, but it is likely that these effects on co-administered drugs can reach to clinical significance leading to potential adverse effects or loss of efficacy. These risks can be evaluated through use of in silico methods of mechanistic modeling, including approaches, such as population pharmacokinetic (PK) and physiologically-based PK modeling, which require a comprehensive understanding of the compounds to ensure accurate predictions. We established a knowledgebase of the available compound (or substance) and interaction-specific parameters with the goal of providing a single source of physiochemical, in vitro, and clinical PK and interaction data of commonly used excipients. To illustrate the utility of this knowledgebase, a model for cremophor EL was developed and used to hypothesize the potential for CYP3A- and P-gp-based interactions as a proof of concept.

 |  New features

Watch our collection of short video tutorials

We have initiated a [How to]… Series of 2-min videos, to show how to search, explore, use, some specific content in DIDB. So far, we have recorded videos on combination drugs, racemate and enantiomers, QT interval prolongation, and drug monographs.

If you have in mind any information you find difficult to retrieve in DIDB, feel free to contact us. We will get back to you and can decide to explain it in a short video.

The videos are available in DIDB Resource Center. Please note that you must be signed in to access.

 |  News

Continuing Education Course on Drug Interactions

Senior team members, Dr Jingjing Yu and Dr Cathy Yeung, are instructing a CE course on Principles & Mechanisms of Pharmacokinetic Drug-Drug Interactions for Recently Approved Drugs which provides pharmaceutical scientists and clinical pharmacists with an in-depth understanding of the mechanisms of drug interactions.

This 5-session course was prepared in collaboration with University of Wisconsin-Madison.

To learn more and register, visit here.