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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.
Tallennettuna:
| Julkaisussa: | Clin Pharmacol Ther |
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| Päätekijät: | , , , |
| Aineistotyyppi: | Artigo |
| Kieli: | Inglês |
| Julkaistu: |
John Wiley and Sons Inc.
2017
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| Aiheet: | |
| Linkit: | https://ncbi.nlm.nih.gov/pmc/articles/PMC5873368/ https://ncbi.nlm.nih.gov/pubmed/29105746 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.899 |
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