Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
8513849 | Journal of Pharmaceutical Sciences | 2017 | 16 Pages |
Abstract
Clinical drug-drug interactions (DDIs) can occur when multiple drugs are taken by the same patient. Significant DDIs can result in clinical toxicity or treatment failure. Therefore, DDI assessment is an integral part of drug development and the benefit-risk assessment of new therapies. Regulatory agencies including the Food and Drug Administration, the European Medicines Agency, and the Pharmaceuticals and Medical Devices Agency of Japan have made recommendations in their DDI guidance documents on various methodologies (in vitro, in silico, and clinical) to assess DDI potential and inform patient management strategies. This commentary focuses on clinical DDI evaluation for the purpose of drug development and regulatory evaluation.
Keywords
Related Topics
Health Sciences
Pharmacology, Toxicology and Pharmaceutical Science
Drug Discovery
Authors
Dinko RekiÄ, Kellie S. Reynolds, Ping Zhao, Lei Zhang, Kenta Yoshida, Madhav Sachar, Micheline Piquette Miller, Shiew-Mei Huang, Issam Zineh,