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Clinical Drug-Drug Interaction Evaluations to Inform Drug Use and Enable Drug Access. 2017

Dinko Rekić, and Kellie S Reynolds, and Ping Zhao, and Lei Zhang, and Kenta Yoshida, and Madhav Sachar, and Micheline Piquette Miller, and Shiew-Mei Huang, and Issam Zineh
AstraZeneca R&D, Gothenburg, Sweden.

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.

UI MeSH Term Description Entries
D007564 Japan A country in eastern Asia, island chain between the North Pacific Ocean and the Sea of Japan, east of the Korean Peninsula. The capital is Tokyo. Bonin Islands
D004347 Drug Interactions The action of a drug that may affect the activity, metabolism, or toxicity of another drug. Drug Interaction,Interaction, Drug,Interactions, Drug
D004363 Drug Utilization The utilization of drugs as reported in individual hospital studies, FDA studies, marketing, or consumption, etc. This includes drug stockpiling, and patient drug profiles. Utilization, Drug,Drug Utilizations,Utilizations, Drug
D004364 Pharmaceutical Preparations Drugs intended for human or veterinary use, presented in their finished dosage form. Included here are materials used in the preparation and/or formulation of the finished dosage form. Drug,Drugs,Pharmaceutical,Pharmaceutical Preparation,Pharmaceutical Product,Pharmaceutic Preparations,Pharmaceutical Products,Pharmaceuticals,Preparations, Pharmaceutical,Preparation, Pharmaceutical,Preparations, Pharmaceutic,Product, Pharmaceutical,Products, Pharmaceutical
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D014481 United States A country in NORTH AMERICA between CANADA and MEXICO.
D014486 United States Food and Drug Administration An agency of the PUBLIC HEALTH SERVICE concerned with the overall planning, promoting, and administering of programs pertaining to maintaining standards of quality of foods, drugs, therapeutic devices, etc. Food and Drug Administration (U.S.),USFDA,Food and Drug Administration,United States Food, Drug Administration
D055030 Drug Users People who take drugs for a non-therapeutic or non-medical effect. The drugs may be legal or illegal, but their use often results in adverse medical, legal, or social consequences for the users. Drug Abusers,Drug Addicts,IV Drug Users,Intravenous Drug Users,People Who Inject Drugs,Abuser, Drug,Abusers, Drug,Addict, Drug,Addicts, Drug,Drug Abuser,Drug Addict,Drug User,Drug User, IV,Drug User, Intravenous,Drug Users, IV,Drug Users, Intravenous,IV Drug User,Intravenous Drug User,User, Drug,User, IV Drug,User, Intravenous Drug,Users, Drug,Users, IV Drug,Users, Intravenous Drug
D018570 Risk Assessment The qualitative or quantitative estimation of the likelihood of adverse effects that may result from exposure to specified health hazards or from the absence of beneficial influences. (Last, Dictionary of Epidemiology, 1988) Assessment, Risk,Benefit-Risk Assessment,Risk Analysis,Risk-Benefit Assessment,Health Risk Assessment,Risks and Benefits,Analysis, Risk,Assessment, Benefit-Risk,Assessment, Health Risk,Assessment, Risk-Benefit,Benefit Risk Assessment,Benefit-Risk Assessments,Benefits and Risks,Health Risk Assessments,Risk Analyses,Risk Assessment, Health,Risk Assessments,Risk Benefit Assessment,Risk-Benefit Assessments

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