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When Enough Is Enough: Decision Criteria for Moving a Known Drug into Clinical Testing for a New Indication in the Absence of Preclinical Efficacy Data.

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Title: When Enough Is Enough: Decision Criteria for Moving a Known Drug into Clinical Testing for a New Indication in the Absence of Preclinical Efficacy Data.
Authors: Pulley JM; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee., Jerome RN; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee., Zaleski NM; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee., Shirey-Rice JK; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee., Pruijssers AJ; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee., Lavieri RR; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee., Chettiar SN; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee., Naylor HM; 2 Center for Knowledge Management, Vanderbilt University Medical Center , Nashville, Tennessee., Aronoff DM; 3 Division of Infectious Diseases, Department of Medicine, Vanderbilt University School of Medicine , Nashville, Tennessee., Edwards DA; 4 Division of Pain Medicine, Department of Anesthesiology, Vanderbilt University School of Medicine , Nashville, Tennessee., Niswender CM; 5 Department of Pharmacology, Vanderbilt Center for Neuroscience Drug Discovery, Vanderbilt University Medical Center , Nashville, Tennessee.; 6 Vanderbilt Kennedy Center for Research on Human Development , Nashville Tennessee., Dugan LL; 7 Division of Geriatric Medicine, Department of Medicine, Vanderbilt University School of Medicine , Nashville, Tennessee., Crofford LJ; 8 Division of Rheumatology and Immunology, Department of Medicine, Vanderbilt University School of Medicine , Nashville, Tennessee., Bernard GR; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee., Holroyd KJ; 1 Vanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center , Nashville, Tennessee.; 9 Center for Technology Transfer and Commercialization, Vanderbilt University , Nashville, Tennessee.
Source: Assay and drug development technologies [Assay Drug Dev Technol] 2017 Dec; Vol. 15 (8), pp. 354-361. Date of Electronic Publication: 2017 Dec 01.
Publication Type: Journal Article
Journal Info: Publisher: Mary Ann Liebert, Inc Country of Publication: United States NLM ID: 101151468 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1557-8127 (Electronic) Linking ISSN: 1540658X NLM ISO Abbreviation: Assay Drug Dev Technol Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Mary+Ann+Liebert%2C+Inc%22">Mary Ann Liebert, Inc </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101151468 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1557-8127 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%221540658X%22">1540658X </searchLink><i>NLM ISO Abbreviation: </i>Assay Drug Dev Technol <i>Subsets: </i>MEDLINE
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        Value: 10.1089/adt.2017.821
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              Text: 2017 Dec
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