Clinical Trials in a Dish

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• 作者：David G. Strauss¹ ; ^{David.Strauss@fda.hhs.gov} ; Ksenia Blinova²
• 刊名：Trends in Pharmacological Sciences
• 出版年：2017
• 出版时间：January 2017
• 年：2017
• 卷：38
• 期：1
• 页码：4-7
• 全文大小：643 K
• 卷排序：38

文摘

Clinical trials ‘in a dish’ involve testing medical therapies for safety or effectiveness in the laboratory with human tissue. This has become possible owing to recent biotechnology advances including induced pluripotent stem cells, organs-on-a-chip, and whole-genome sequencing. We provide here an overview of the landscape and highlight steps the FDA is taking to advance the science of clinical trials in a dish and to support the development and validation of new regulatory paradigms to assess drug safety using these new technologies.