Drug safety sciences and the bottleneck in drug development

During a recent review of a new drug application for treatment of a chronic disease, US Food and Drug Administration (FDA) regulators agreed with the sponsor's assessment of efficacy. However, it was noted that two subjects receiving active treatment experienced abnormal liver chemistries that...

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Veröffentlicht in:	Clinical pharmacology and therapeutics Jg. 89; H. 6; S. 788
1. Verfasser:	Watkins, P B
Format:	Journal Article
Sprache:	Englisch
Veröffentlicht:	United States 01.06.2011
Schlagworte:	Animals Clinical Trials as Topic - economics Clinical Trials as Topic - methods Drug Approval - economics Drug Approval - methods Drug Discovery - economics Drug Discovery - methods Drug Discovery - standards Drug-Related Side Effects and Adverse Reactions - economics Drug-Related Side Effects and Adverse Reactions - prevention & control Humans United States United States
ISSN:	1532-6535, 1532-6535
Online-Zugang:	Weitere Angaben
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