definition of a “clinical trial” for the purposes of Directive 2001/20/EC 1 . A clear understanding of the definition of an IMP requires knowledge of the definitions of a medicinal product and of a clinical trial; these two definitions are provided in Annex A. An algorithm and its ...
In this discourse, several unique ethical and regulatory concerns related to the direct negotiation of access to IMP for minor patients are identified, with a focus on product safety, the recruitment of research subjects, the unnoticed entry of market mechanisms in the recruitment of research ...
描述产品或技术的使用状态:在某些情况下,'investigational'还用于描述某些产品或技术当前仅限于研究或试验使用,尚未获得广泛认可或批准。例如,“The medical device is currently limited to investigational use in clinical trials.”(该医疗设备目前仅限于在临床试验中进行研究使用。) 'Inves...
Investigational medicinal product dossier , VERSION AUTHORS TABLE OF CONTENTS Explanatory text: The table of contents for the pharmaceutical part follows the headings as given by the guidelines. The table of contents for the pre-clinical medical parts is based on the assumption that the detailed ...
Overcoming regulatory issues with investigational medicinal product labelling Accuracy is vital for the text on labels of medical products, especially with language barriers between manufacturers and patients. Credit: via Shutterstock. Meeting strict client timelines is essential for clinical...
Early Access Care connects patients with serious medical conditions to investigational medicinal products when all treatments are exhausted. Learn more!
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investigational是什么意思 n. (名词) 调查 研究 审查 研究论文 调查报告 试验 勘探 勘测 侦查 科学研究 学术研究 系统的调查研究 investigational英英释义 adjective of or relating to investigation investigational activities relating to or being a drug or medical procedure that is not approved for general use...
“an experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. Such an experiment is any use of a drug [whether approved or unapproved] except for the use of a marketed drug ...