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

Robert N. Schuck,Michael Pacanowski,Janet Woodcock,Issam Zineh

NATURE REVIEWS DRUG DISCOVERY（2017）

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摘要

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.

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关键词

Biomarkers,Drug development,Drug regulation,Drug therapy,Biomedicine,general,Pharmacology/Toxicology,Biotechnology,Medicinal Chemistry,Molecular Medicine,Cancer Research

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