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Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective
The European Medicines Agency (EMA) revises its guideline on minimizing risk in first‐in‐human trials to reflect changing practice and in light of a recent tragic incident.
| Autores principales: | , , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2017
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5873368/ https://www.ncbi.nlm.nih.gov/pubmed/29105746 http://dx.doi.org/10.1002/cpt.899 |
| _version_ | 1783310022583779328 |
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| author | Ponzano, Stefano Blake, Kevin Bonelli, Milton Enzmann, Harald |
| author_facet | Ponzano, Stefano Blake, Kevin Bonelli, Milton Enzmann, Harald |
| author_sort | Ponzano, Stefano |
| collection | PubMed |
| description | The European Medicines Agency (EMA) revises its guideline on minimizing risk in first‐in‐human trials to reflect changing practice and in light of a recent tragic incident. |
| format | Online Article Text |
| id | pubmed-5873368 |
| institution | National Center for Biotechnology Information |
| language | English |
| publishDate | 2017 |
| publisher | John Wiley and Sons Inc. |
| record_format | MEDLINE/PubMed |
| spelling | pubmed-58733682018-03-29 Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective Ponzano, Stefano Blake, Kevin Bonelli, Milton Enzmann, Harald Clin Pharmacol Ther Perspectives The European Medicines Agency (EMA) revises its guideline on minimizing risk in first‐in‐human trials to reflect changing practice and in light of a recent tragic incident. John Wiley and Sons Inc. 2017-11-06 2018-04 /pmc/articles/PMC5873368/ /pubmed/29105746 http://dx.doi.org/10.1002/cpt.899 Text en © 2017 The Authors Clinical Pharmacology & Therapeutics published by Wiley Periodicals, Inc. on behalf of American Society for Clinical Pharmacology and Therapeutics This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs (http://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
| spellingShingle | Perspectives Ponzano, Stefano Blake, Kevin Bonelli, Milton Enzmann, Harald Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective |
| title | Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective |
| title_full | Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective |
| title_fullStr | Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective |
| title_full_unstemmed | Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective |
| title_short | Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective |
| title_sort | promoting safe early clinical research of novel drug candidates: a european union regulatory perspective |
| topic | Perspectives |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5873368/ https://www.ncbi.nlm.nih.gov/pubmed/29105746 http://dx.doi.org/10.1002/cpt.899 |
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