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Volumn 65, Issue 3, 2012, Pages 93-101

Best practice in the conduct of key nonclinical cardiovascular assessments in drug development: Current recommendations from the Safety Pharmacology Society

Author keywords

Cardiovascular; Dogs; Methods; Monkeys; QT Prolongation; Safety Pharmacology

Indexed keywords

ATORVASTATIN; SIBUTRAMINE; TORCETRAPIB;

EID: 84861481556     PISSN: 10568719     EISSN: 1873488X     Source Type: Journal    
DOI: 10.1016/j.vascn.2011.08.006     Document Type: Article
Times cited : (85)

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