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对RNA寡核酸的首次人体研究的评估

Sydney Stern1, Ronald L Wange2, Hobart Rogers1

  • 1Center for Drug Evaluation and Research, Office of Translational Science, Office of Clinical Pharmacology, US Food and Drug Administration, Silver Spring, Maryland, USA.

Nucleic acid therapeutics
|September 23, 2024
PubMed
概括

预测治疗性寡核类药物的人体剂量需要仔细考虑动物研究数据. 本次审批药物和早期试验的审查揭示了首次在人体研究中选择剂量的常见做法.

关键词:
这是一种反意义的寡核酸.药物开发是药物的发展.这是一种寡核化物.siRNA 是一个RNA.

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