The translational path includes the FDA's critical path.

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超能文献

作者信息

Woosley Raymond L

机构信息

The Critical Path Institute, Tucson, AZ 85718, USA.

出版信息

J Cardiovasc Transl Res. 2008 Sep;1(3):188-9. doi: 10.1007/s12265-008-9043-z. Epub 2008 Aug 11.

DOI:10.1007/s12265-008-9043-z

PMID:20559915

Abstract

摘要

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本文引用的文献

The Predictive Safety Testing Consortium: A synthesis of the goals, challenges and accomplishments of the Critical Path.

Drug Discov Today Technol. 2007 Winter;4(2):47-50. doi: 10.1016/j.ddtec.2007.10.010.

The FDA critical path initiative and its influence on new drug development.

Annu Rev Med. 2008;59:1-12. doi: 10.1146/annurev.med.59.090506.155819.

Biomarker qualification pilot process at the US Food and Drug Administration.

AAPS J. 2007 Mar 23;9(1):E105-8. doi: 10.1208/aapsj0901010.

Drug development and the FDA's Critical Path Initiative.

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