Use of pharmaceuticals ‘Off-Label’ in the neonate

Neonates are frequently not studied in the development of a novel pharmacological agent. With lack of data to support safe and effective use of a new agent in this population, sponsors will not receive approval for labelling the agent for use in this age group from the United States Food and Drug Ad...

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Veröffentlicht in:	Best practice & research. Clinical anaesthesiology 2010-09, Vol.24 (3), p.451-460
1. Verfasser:	Tobin, Joseph R., MD
Format:	Artikel
Sprache:	eng
Schlagworte:	anaesthesia Anesthesia & Perioperative Care Clinical Trials as Topic Drug Approval Humans Infant, Newborn neonate Nitric Oxide - administration & dosage off-label Off-Label Use pharmacology
Online-Zugang:	Volltext
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