A safety grading scale to support dose escalation and define stopping rules for healthy subject first-entry-into-man studies: Some points to consider from the French Club Phase I* working group

British Journal of Clinical Pharmacology

Volumn 70, Issue 5, 2010, Pages 736-748

  Sibille, Michel ^a   Patat, Alain ^b   Caplain, Henri ^c   Donazzolo, Yves ^d  

^a CENTRE HOSPITALIER LYON SUD   (France)

^b Biotrial SA   (France)

^c SANOFI   (France)

^d OPTIMED Clinical Research   (France)

Author keywords

Dose escalation; Grading; Healthy subjects; Phase 1; Stopping rules

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BILIRUBIN; CREATINE KINASE; CREATININE; GLUCOSE; HEMOGLOBIN; POTASSIUM;

ADVERSE DRUG REACTION; ARTICLE; COGNITIVE DEFECT; CONFUSION; DAILY LIFE ACTIVITY; DIARRHEA; DIASTOLIC BLOOD PRESSURE; DISORIENTATION; DIZZINESS; DROWSINESS; DRUG DOSE ESCALATION; DRUG SAFETY; DRUG WITHDRAWAL; ELECTROCARDIOGRAM; EOSINOPHIL; FATIGUE; FOOD AND DRUG ADMINISTRATION; HEADACHE; HEART RATE; HUMAN; LABORATORY TEST; MALAISE; MALE; MYALGIA; NAUSEA; NORMAL VALUE; PRIORITY JOURNAL; SCORING SYSTEM; SOMNOLENCE; SYNCOPE; SYSTOLIC BLOOD PRESSURE; THROMBOCYTE; VITAL SIGN; VOMITING;

CLINICAL TRIALS, PHASE I AS TOPIC; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUGS, INVESTIGATIONAL; HUMANS;

EID: 78649245021     PISSN: 03065251     EISSN: 13652125     Source Type: Journal    
DOI: 10.1111/j.1365-2125.2010.03741.x     Document Type: Article

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