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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.

Shranjeno v:
Bibliografske podrobnosti
izdano v:Clin Pharmacol Ther
Main Authors: Ponzano, Stefano, Blake, Kevin, Bonelli, Milton, Enzmann, Harald
Format: Artigo
Jezik:Inglês
Izdano: John Wiley and Sons Inc. 2017
Teme:
Online dostop: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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