医学
干细胞
细胞疗法
临床试验
重症监护医学
风险分析(工程)
病理
生物
遗传学
作者
Alys Bradley,Lauren D. Black
标识
DOI:10.1177/0192623319897898
摘要
Although there is an increase in the development of new cellular therapies, few guidelines have been published to assist in the design of preclinical studies. As no product and therapeutic intention is entirely alike regulators and Contract Research Organizations need to treat each project on a case-by-case basis. One of the most important considerations in study design is to retain all tissues from the study, thereby allowing for further analysis of tissues should unexpected effects be seen in clinical studies. Input from the pathologist at the earliest stages of study design regarding animal selection, cell markers, and phased tissue examination improves the scientific integrity of the study.
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