Critical limits to define a lab adverse event during phase I studies: A study in 1134 subjects

European Journal of Clinical Pharmacology

Volumn 52, Issue 2, 1997, Pages 81-86

  Sibille, M ^a,b   Bresson, V ^b   Janin, A ^b   Boutouyrie, B ^a   Rey, J ^a   Vital Durand, D ^b  

^a SANOFI   (France)

^b CENTRE HOSPITALIER LYON SUD   (France)

Author keywords

Adverse events; critical limits; drug developments; Phase I study

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ANTIINFECTIVE AGENT; ANTIINFLAMMATORY AGENT; ASPARTATE AMINOTRANSFERASE; CARDIOVASCULAR AGENT; CREATININE; IMMUNOLOGIC AGENT; PSYCHOTROPIC AGENT; RESPIRATORY TRACT AGENT;

ADULT; ADVERSE DRUG REACTION; ANALYTIC METHOD; ARTICLE; CLINICAL TRIAL; DOSE RESPONSE; DRUG DEVELOPMENT; HUMAN; LABORATORY DIAGNOSIS; LEUKOCYTE COUNT; MALE; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; REFERENCE VALUE;

ADOLESCENT; ADULT; ALANINE TRANSAMINASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASES; CLINICAL TRIALS, PHASE I; CREATININE; CROSS-OVER STUDIES; HUMANS; MALE; NEUTROPHILS; PHARMACEUTICAL PREPARATIONS; REFERENCE VALUES;

EID: 0030996788     PISSN: 00316970     EISSN: None     Source Type: Journal    
DOI: 10.1007/s002280050254     Document Type: Article

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