概述
Concomitant medication use is widespread and presents a risk for patients in clinical trials and real world treatment settings. The risk is greater for older adults and patients with chronic conditions.
While automated warning systems act as a safeguard for patients prescribed licensed medications, protections against drug-drug interactions (DDIs) for clinical trials involving investigational medicinal products are often incomplete or inconsistent, leaving patients dvulnerable to harmful adverse events.
The latest innovation built on Certara’s Drug Interaction Database (DIDB®) platform is the most complete, interactive list of drug interaction characteristics available today, with up to 5-6X the number of compounds and characteristics compared to publicly-available resources like the FDA and ICH. The Concomitant Meds Navigator is an essential, evidence-based tool for pharmaceutical sponsors and clinical researchers to greatly improve DDI management during clinical trials, particularly in early development when accurate instructions are challenging to obtain. By quickly identifying concomitant medications that are contraindicated, require dose adjustments, or need monitoring during the trial, the Navigator minimizes the risk of pharmacokinetic drug interactions and enables the safe and effective evaluation of investigational products.
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杰出科学家
Dr. Ragueneau 是华盛顿大学的荣誉临床教授，25 年前，她与他人共同创建了药物相互作用数据库 (DIDB)。At Certara, she is the head of the Drug Interaction Solutions program. Isabelle is a clinical pharmacologist by training, with a deep expertise in the evaluation of drug-drug interactions mechanisms and clinical significance. 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。
Senior Research Scientist
Dr. Owens joined the Drug Interaction Database (DIDB) team in March 2015 as a curator of preclinical and drug interaction studies. She holds a PhD in clinical pharmacy from the School of Pharmacy, University of Otago (Dunedin, New Zealand) as well as a Bachelor of Pharmacy (BPharm). Katie’s PhD research investigated the clinical pharmacology and toxicology of paracetamol (acetaminophen) in various patient populations. This was followed by a post-doctoral research position in the area of modeling and simulation in drug development within the Division of Clinical Pharmacokinetics and Pharmacometrics, Institut de Recherches Internationales Servier (Paris, France).
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