Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development.
Microdosing and Other Phase 0 Clinical Trials: Facilitating Translation in Drug Development.
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DOI：
10.1111/cts.12390
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发表时间：
2016-04
期刊：
影响因子：
--
通讯作者：
Rowland M
中科院分区：
文献类型：
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作者：
Burt T;Yoshida K;Lappin G;Vuong L;John C;de Wildt SN;Sugiyama Y;Rowland M
药物开发成本的增加以及对人类和动物暴露于新型化学实体风险的伦理担忧有利于有限暴露临床试验，例如微剂量和其他 0 期试验。越来越多的研究支持从 0 期方法的有限药物暴露到全面治疗暴露的推断的有效性。越来越多的应用和设计选项证明了这些方法为药物开发商提供的多功能性和灵活性。
Increasing costs of drug development and ethical concerns about the risks of exposing humans and animals to novel chemical entities favor limited exposure clinical trials such as microdosing and other phase 0 trials. An increasing body of research supports the validity of extrapolation from the limited drug exposure of phase 0 approaches to the full, therapeutic exposure. An increasing number of applications and design options demonstrate the versatility and flexibility these approaches offer to drug developers.