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Academia and industry agreement on a feasibility tool for first-time-in-human clinical trial units.

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Title: Academia and industry agreement on a feasibility tool for first-time-in-human clinical trial units.
Authors: Moraga P; Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain., Prieto P; Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain., Conradie A; Global Alliance for TB Drug Development (TB Alliance), New York, New York, USA., Benhayoun M; Global Alliance for TB Drug Development (TB Alliance), New York, New York, USA., Rousell V; GlaxoSmithKline, London, UK., Davy M; GlaxoSmithKline, London, UK., Fuhr U; Department of Pharmacology, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, University of Cologne, Cologne, Germany., Antonijoan Arbos R; Clinical Pharmacology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.; Drug Research Center, Institut d'Investigació Biomèdica Sant Pau, IIB Sant Pau, Barcelona, Spain.; Pharmacology and Therapeutics Department, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain., Abad-Santos F; Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain., Portolés A; Clinical Pharmacology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, IdISSC, Madrid, Spain.; Pharmacology and Toxicology Department, School of Medicine, Universidad Complutense de Madrid (UCM), Madrid, Spain., Van Duinen J; QPS Netherlands BV, Groningen, The Netherlands., Carcas AJ; Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.; Pharmacology Department, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain., Borobia AM; Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.; Pharmacology Department, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.
Corporate Authors: ERA4TB Consortium
Source: Clinical and translational science [Clin Transl Sci] 2023 Dec; Vol. 16 (12), pp. 2421-2428. Date of Electronic Publication: 2023 Oct 11.
Publication Type: Journal Article; Research Support, Non-U.S. Gov't
Journal Info: Publisher: WileyBlackwell Pub Country of Publication: United States NLM ID: 101474067 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1752-8062 (Electronic) Linking ISSN: 17528054 NLM ISO Abbreviation: Clin Transl Sci Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Academia and industry agreement on a feasibility tool for first-time-in-human clinical trial units.
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  Data: <searchLink fieldCode="AU" term="%22Moraga+P%22">Moraga P</searchLink>; Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Prieto+P%22">Prieto P</searchLink>; Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Conradie+A%22">Conradie A</searchLink>; Global Alliance for TB Drug Development (TB Alliance), New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Benhayoun+M%22">Benhayoun M</searchLink>; Global Alliance for TB Drug Development (TB Alliance), New York, New York, USA.<br /><searchLink fieldCode="AU" term="%22Rousell+V%22">Rousell V</searchLink>; GlaxoSmithKline, London, UK.<br /><searchLink fieldCode="AU" term="%22Davy+M%22">Davy M</searchLink>; GlaxoSmithKline, London, UK.<br /><searchLink fieldCode="AU" term="%22Fuhr+U%22">Fuhr U</searchLink>; Department of Pharmacology, Faculty of Medicine and University Hospital Cologne, Center for Pharmacology, University of Cologne, Cologne, Germany.<br /><searchLink fieldCode="AU" term="%22Antonijoan+Arbos+R%22">Antonijoan Arbos R</searchLink>; Clinical Pharmacology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.; Drug Research Center, Institut d'Investigació Biomèdica Sant Pau, IIB Sant Pau, Barcelona, Spain.; Pharmacology and Therapeutics Department, Universitat Autònoma de Barcelona (UAB), Bellaterra, Spain.<br /><searchLink fieldCode="AU" term="%22Abad-Santos+F%22">Abad-Santos F</searchLink>; Clinical Pharmacology Department, Hospital Universitario de La Princesa, Instituto Teófilo Hernando, Universidad Autónoma de Madrid (UAM), Instituto de Investigación Sanitaria La Princesa (IP), Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Portolés+A%22">Portolés A</searchLink>; Clinical Pharmacology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, IdISSC, Madrid, Spain.; Pharmacology and Toxicology Department, School of Medicine, Universidad Complutense de Madrid (UCM), Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Van+Duinen+J%22">Van Duinen J</searchLink>; QPS Netherlands BV, Groningen, The Netherlands.<br /><searchLink fieldCode="AU" term="%22Carcas+AJ%22">Carcas AJ</searchLink>; Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.; Pharmacology Department, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.<br /><searchLink fieldCode="AU" term="%22Borobia+AM%22">Borobia AM</searchLink>; Clinical Pharmacology Department, La Paz University Hospital, IdiPAZ, Madrid, Spain.; Pharmacology Department, School of Medicine, Universidad Autónoma de Madrid, Madrid, Spain.; Centro de Investigación Biomédica en Red de Enfermedades Infecciosas, Instituto de Salud Carlos III, Madrid, Spain.
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  Data: <searchLink fieldCode="JN" term="%22101474067%22">Clinical and translational science</searchLink> [Clin Transl Sci] 2023 Dec; Vol. 16 (12), pp. 2421-2428. <i>Date of Electronic Publication: </i>2023 Oct 11.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22WileyBlackwell+Pub%22">WileyBlackwell Pub </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101474067 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1752-8062 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2217528054%22">17528054 </searchLink><i>NLM ISO Abbreviation: </i>Clin Transl Sci <i>Subsets: </i>MEDLINE
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              Text: 2023 Dec
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