Managing drug-drug interaction (DDI) risk in clinical trials is a critical part of protecting patients and ensuring successful trials. Yet investigational drugs often enter development with limited DDI data, requiring clinical pharmacologists to make informed decisions using in vitro studies, PBPK modeling, and early clinical evidence. Combined with fragmented information across the literature, regulatory documents, and internal resources, developing consistent DDI strategies can be challenging.
In this white paper, learn how the Drug Interaction Database (DIDB®), particularly the Concomitant Meds Navigator, helps streamline DDI risk assessment with scientifically curated data, enabling faster, more consistent, and evidence-based decision-making throughout clinical development.
What you’ll learn
- How DIDB supports DDI assessments aligned with the ICH M12 guideline
- How the Concomitant Meds Navigator enables rapid identification of medications for prohibited drug lists in clinical trials
- How customizable filters, pharmacokinetic information, and study details support faster clinical decision-making
- How DIDB classifies substrates, inhibitors, and inducers of metabolizing enzymes and transporters using curated clinical and in silico evidence
- How integrated access to study details and data resources strengthens confidence in DDI assessments
- How centralized DDI intelligence helps improve consistency across development programs and reduce protocol amendments
Authors
Katie Owens, PhD
Senior Research Scientist
Dr. Katie Owens is a Senior Research Scientist at Certara, which she joined with the Drug Interaction Solutions (DIS) team in 2023 from the University of Washington. A registered pharmacist with over ten years of experience in clinical pharmacology and drug safety, she specializes in assessing drug-drug interactions (DDIs) and evaluating their clinical relevance. Katie completed her BPharm and PhD at the University of Otago (New Zealand), followed by a postdoctoral position in clinical pharmacokinetics and pharmacometrics at Servier (France).
在收购华盛顿大学药物相互作用解决方案项目后，Dr. Yu 于 2023 年加入 Certara。她在药物代谢和临床药理学领域拥有超过 15 年的经验，通过在学术界和工业界的工作，她在药物相互作用领域积累了独特的专业知识。在 Certara，Dr. Yu 是药物相互作用解决方案总监，也是药物相互作用科学卓越中心的核心成员。她还是华盛顿州西雅图华盛顿大学制药系的副教授。
Isabelle Ragueneau-Majlessi, MD, MS
杰出科学家
Dr. Ragueneau is a Clinical Professor Emeritus from the University of Washington where she co-founded the Drug Interaction Database or DIDB over 25 years ago. 在 Certara，她是药物相互作用解决方案项目的负责人，并领导药物相互作用科学卓越中心。她是一名临床药理学家，在评估药物相互作用机制和临床意义方面具有深厚的专业知识。2022 年，她因在药物相互作用数据库方面所做的大量工作以及该工具对药物相互作用研究的影响，获得了美国药物滥用和不良反应学会颁发的 Gary Neil 药物开发创新奖。
