Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease
Nature Reviews Drug Discovery 17, 79 (2018).
doi:10.1038/nrd.2017.231
Authors: Robert N. Schuck, Michael Pacanowski, Janet Woodcock & Issam Zineh
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.
Source: Nature Reviews Drug Discovery - Category: Drugs & Pharmacology Authors: Robert N. Schuck Michael Pacanowski Janet Woodcock Issam Zineh Tags: Comment Source Type: research
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