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
Dr. Yu joined Certara in 2023 following the acquisition of the University of Washington Drug Interaction Solutions program. With over 15 years of experience in drug metabolism and clinical pharmacology, she brings a unique expertise in the field of drug interactions, gained through her work in both academia and industry. At Certara, Dr. Yu is Director at the Drug Interaction Solutions and a core member of Center of Excellence in Drug Interaction Science. She is also an Affiliate Associate Professor of the Department of Pharmaceutics at the University of Washington in Seattle, WA.
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. At Certara, she is the head of the Drug Interaction Solutions program and leads the Center of Excellence in Drug Interaction Science. She is a clinical pharmacologist by training, with a deep expertise in the evaluation of drug-drug interactions mechanisms and clinical significance. In 2022, she received the Gary Neil prize for innovation in drug development from the ASCPT in recognition of her extensive work with the DIDB and the impact of the tool on drug interaction research.
