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Volumn 65, Issue 10, 2009, Pages 1025-1035

Reexamining transaminase elevation in Phase i clinical trials: The importance of baseline and change from baseline

Author keywords

Alanine transaminase; Aminotransferase; Elevation rate; Healthy volunteers; Upper limit of normal values

Indexed keywords

ALANINE AMINOTRANSFERASE; PLACEBO;

EID: 70349229295     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00228-009-0684-x     Document Type: Article
Times cited : (22)

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