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Title Guidance for industry [electronic resource] : drug-induced liver injury, premarketing clinical evaluation.

Imprint Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research : Center for Biologics Evaluation and Research, [2007]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:D 8/4/DRAFT    ---  Available
Description 23 p. : digital, PDF file
System Details Mode of access via the FDB CBER web site.
Note Title from PDF title page (viewed on May 5, 2009).
"Draft guidance".
"Drug safety".
"October 2007".
Bibliography Includes bibliographical references (p. 17-20).
Subject Liver -- Failure.
Drugs -- Side effects.
Drugs -- Testing.
Added Author Center for Drug Evaluation and Research (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Added Title Drug-induced liver injury, premarketing clinical evaluation
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:D 8/4/DRAFT

 
    
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