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Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective

Clinical Pharmacology and Therapeutics
DOI: 10.1002/cpt.899
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Abstract

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.

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Ponzano, S., Blake, K., Bonelli, M., & Enzmann, H. (2018, April 1). Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective. Clinical Pharmacology and Therapeutics. Nature Publishing Group. https://doi.org/10.1002/cpt.899

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