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EANM 剂量学委员会指导文件:临床剂量报告的良好实践。

EANM Dosimetry Committee guidance document: good practice of clinical dosimetry reporting.

机构信息

Department of Nuclear Medicine, University of Würzburg, Oberdürrbacher Str. 6, 97080, Würzburg, Germany.

出版信息

Eur J Nucl Med Mol Imaging. 2011 Jan;38(1):192-200. doi: 10.1007/s00259-010-1549-3. Epub 2010 Aug 27.

DOI:10.1007/s00259-010-1549-3
PMID:20799035
Abstract

Many recent publications in nuclear medicine contain data on dosimetric findings for existing and new diagnostic and therapeutic agents. In many of these articles, however, a description of the methodology applied for dosimetry is lacking or important details are omitted. The intention of the EANM Dosimetry Committee is to guide the reader through a series of suggestions for reporting dosimetric approaches. The authors are aware of the large amount of data required to report the way a given clinical dosimetry procedure was implemented. Another aim of this guidance document is to provide comprehensive information for preparing and submitting publications and reports containing data on internal dosimetry. This guidance document also contains a checklist which could be useful for reviewers of manuscripts submitted to scientific journals or for grant applications. In addition, this document could be used to decide which data are useful for a documentation of dosimetry results in individual patient records. This may be of importance when the approval of a new radiopharmaceutical by official bodies such as EMA or FDA is envisaged.

摘要

许多最近的核医学出版物都包含有关现有和新的诊断和治疗药物的剂量学发现的数据。然而,在这些文章中的许多文章中,缺乏对应用于剂量学的方法的描述,或者省略了重要的细节。EANM 剂量学委员会的目的是通过一系列报告剂量学方法的建议来指导读者。作者意识到报告特定临床剂量学程序实施方式所需的大量数据。本指南文件的另一个目的是为准备和提交包含内部剂量学数据的出版物和报告提供全面的信息。本指南文件还包含一份检查表,对于提交给科学期刊的手稿的审稿人或资助申请可能很有用。此外,当预计 EMA 或 FDA 等官方机构批准新放射性药物时,该文件可用于确定哪些数据对个别患者记录中的剂量学结果的记录有用。

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