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Promoting Safe Early Clinical Research of Novel Drug Candidates: A European Union Regulatory Perspective
Author(s) -
Ponzano Stefano,
Blake Kevin,
Bonelli Milton,
Enzmann Harald
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.899
Subject(s) - european union , perspective (graphical) , drug development , drug , drug approval , regulatory science , medicine , pharmacology , business , computer science , international trade , pathology , artificial intelligence
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.