PDF(Pubmed)
Abstract：
The numbers of diagnostic and therapeutic nuclear medicine agents under investigation are rapidly increasing. Both novel emitters and novel carrier molecules require careful selection of measurement procedures. This document provides guidance relevant to dosimetry for first-in human and early phase clinical trials of such novel agents. The guideline includes a short introduction to different emitters and carrier molecules, followed by recommendations on the methods for activity measurement, pharmacokinetic analyses, as well as absorbed dose calculations and uncertainty analyses. The optimal use of preclinical information and studies involving diagnostic analogues is discussed. Good practice reporting is emphasised, and relevant dosimetry parameters and method descriptions to be included are listed. Three examples of first-in-human dosimetry studies, both for diagnostic tracers and radionuclide therapies, are given.
摘要：
正在研究的诊断和治疗核医学试剂的数量正在迅速增加。新型发射器和新型载体分子都需要仔细选择测量程序。本文件为此类新型药物的首次人体和早期临床试验提供了与剂量学相关的指导。该指南包括对不同发射器和载体分子的简短介绍，随后是关于活动测量方法的建议，药代动力学分析，以及吸收剂量计算和不确定性分析。讨论了涉及诊断类似物的临床前信息和研究的最佳使用。强调良好做法报告，并列出了相关的剂量测定参数和方法说明。人类首次剂量学研究的三个例子，用于诊断示踪剂和放射性核素治疗，是给定的。
