Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease

Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease, Published online: 22 December 2017; doi:10.1038/nrd.2017.231

Numerous challenges arise when developing targeted therapies for diseases comprising low-frequency molecular subtypes. In this article, we describe a pragmatic, science-based regulatory policy for the development and approval of targeted therapies in such cases.

中文翻译：

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制定针对低频分子亚型疾病的靶向疗法的监管政策

制定针对低频分子亚型疾病的靶向疗法的监管政策

制定针对低频分子亚型疾病的靶向疗法的监管政策，在线发布：2017年12月22日；doi：10.1038 / nrd.2017.231

当开发针对包括低频分子亚型的疾病的靶向疗法时，出现了许多挑战。在本文中，我们描述了一种务实的，基于科学的监管政策，用于在这种情况下开发和批准靶向疗法。