Paediatric labelling requirements : implications for pharmacokinetic studies

The US Food and Drug Administration (FDA) has proposed new labelling regulations that describe alternative approaches for providing additional information to support labelling a drug, already approved for use in adults, for use in children. Therefore, the study of drugs in paediatric populations may...

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Veröffentlicht in:	Clinical pharmacokinetics 1994-04, Vol.26 (4), p.308-325
Hauptverfasser:	WILSON, J. T, KEARNS, G. L, MURPHY, D, YAFFE, S. J
Format:	Artikel
Sprache:	eng
Schlagworte:	Aging - metabolism Biological and medical sciences Child Child, Preschool Dose-Response Relationship, Drug Drug Labeling - legislation & jurisprudence General pharmacology Humans Infant Infant, Newborn Medical sciences Pediatrics Pharmacokinetics Pharmacokinetics. Pharmacogenetics. Drug-receptor interactions Pharmacology. Drug treatments United States United States Food and Drug Administration
Online-Zugang:	Volltext
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