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).
Jingjing Yu, MD, PhD
Director
Yu 博士は、ワシントン大学の薬物相互作用ソリューション(DIDB)の買収に伴い、 2023年にサターラに入社しました。薬物代謝と臨床薬理学の分野で15年以上の経験を持ち、学術界と産業界の両方での業務を通じて得た、薬物相互作用の分野における独自の専門知識が強みです。サターラでは、薬物相互作用ソリューション部門のディレクターであり、薬物相互作用研究の中核メンバーでもあります。また、ワシントン州シアトルにあるワシントン大学の薬剤学部の非常勤准教授も務めています。
Isabelle Ragueneau-Majlessi, MD, MS
Distinguished Scientist
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. サターラでは薬物相互作用ソリューションプログラムの責任者を務め、薬物相互作用の研究チームを率いています。彼女は臨床薬理学者として、薬物間相互作用のメカニズムと臨床的意義の評価に関する深い専門知識を誇ります。2022年には、DIDBに関する広範な業務と、薬物相互作用研究におけるツールの貢献が評価され、ASCPTから医薬品開発におけるイノベーションを称えるゲリー・ニール賞を受賞しました。
