Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease
Author:
Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmacology,General Medicine
Link
http://www.nature.com/articles/nrd.2017.231.pdf
Reference3 articles.
1. Pacanowski, M. A., Leptak, C. & Zineh, I. Next-generation medicines: past regulatory experience and considerations for the future. Clin. Pharmacol. Ther. 95, 247–249 (2014).
2. Biankin, A. V., Piantadosi, S. & Hollingsworth, S. J. Patient-centric trials for therapeutic development in precision oncology. Nature 526, 361–370 (2015).
3. Durmowicz, A. G. et al. The FDA's experience with ivacaftor in cystic fibrosis: establishing efficacy using in vitro data in lieu of a clinical trial. Ann. Am. Thorac. Soc. https://dx.doi.org/10.1513/AnnalsATS.201708-668PS (2017).
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