Commentary on "Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies" by Sievers et al.
作者信息
Rissmann Robert, Zuiker Rob
机构信息
Centre for Human Drug Research, Leiden, The Netherlands.
Leiden Academic Centre for Drug Research, Leiden University, Leiden, The Netherlands.
出版信息
Br J Clin Pharmacol. 2021 Jul;87(7):2633-2634. doi: 10.1111/bcp.14823. Epub 2021 Mar 24.
Abstract
摘要
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Commentary on "Investigator brochures for phase I/II trials lack information on the robustness of preclinical safety studies" by Sievers et al.西弗斯等人对《I/II期试验的研究者手册缺乏临床前安全性研究稳健性的信息》的评论
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本文引用的文献
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How to Interpret an Investigator's Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum.如何解读研究者手册以进行有意义的风险评估：AGA 讨论论坛的结果。
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