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4. Liver Safety Assessment: Required Data Elements and Best Practices for Data Collection and Standardization in Clinical Trials
作者：Mark I. Avigan (1)
Einar S. Bjornsson (2)
Markku Pasanen (3)
Charles Cooper (4)
Raul J. Andrade (5)
Paul B. Watkins (6) (9)
James H. Lewis (7)
Michael Merz (8)

1. Office of Surveillance and Epidemiology ; Center for Drug Evaluation and Research ; Food and Drug Administration ; 10903 New Hampshire Avenue ; Silver Spring ; MD ; 20993 ; USA
2. The National University Hospital of Iceland ; Reykjav铆k ; Iceland
3. Faculty of Health Sciences ; School of Pharmacy Kuopio ; University of Eastern Finland ; Kuopio ; Finland
4. Becton Dickenson ; Franklin Lakes ; NJ ; USA
5. Gastroenterology Service and Liver Unit ; Centro de Investigaci贸n Biom茅dica en Red de Enfermedades Hep谩ticas y Digestivas (CIBERehd) ; Instituto de Investigaci贸n Biom茅dica de M谩laga (IBIMA) ; University Hospital Virgen de la Victoria ; Universidad de M谩laga ; Malaga ; Spain
6. The Hamner-University of North Carolina Institute for Drug Safety Sciences ; 6 Davis Drive ; PO Box 12137 ; Research Triangle Park ; NC ; 27709 ; USA
9. Schools of Medicine ; Pharmacy and Public Health ; University of North Carolina ; Chapel Hill ; NC ; USA
7. Georgetown University ; Washington ; DC ; USA
8. Discovery and Investigative Safety ; Novartis Institutes for BioMedical Research ; Basel ; Switzerland
刊名：Drug Safety
出版年：2014
1
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