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

نویسندگان

  • Stefano Ponzano
  • Kevin Blake
  • Milton Bonelli
  • Harald Enzmann
چکیده

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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عنوان ژورنال:

دوره 103  شماره 

صفحات  -

تاریخ انتشار 2018