Evaluating benefit-risk during and beyond drug development: An industry view

Regulatory Rapporteur

Volumn 9, Issue 6, 2012, Pages 10-15

  Levitan, Bennett ^a   Mussen, Filip ^b  

^a JANSSEN RESEARCH AND DEVELOPMENT   (United States)

^b JANSSEN RESEARCH AND DEVELOPMENT   (Belgium)

Author keywords

Benefit risk; Benefit risk action team (BRAT) framework; Evaluation; Forest plot; Measures; Methodology; Outcomes; Qualitative semiquantitative quantitative frameworks

Indexed keywords

TRIPTAN DERIVATIVE;

ACUTE DISEASE; ARTHRALGIA; AUSTRALIA; BLEEDING; BRAIN HEMORRHAGE; CANADA; CENTRAL NERVOUS SYSTEM DISEASE; CLINICAL TRIAL (TOPIC); DECISION MAKING; DRUG RESEARCH; HEADACHE; HUMAN; INTENTION TO TREAT ANALYSIS; MIGRAINE; NAUSEA AND VOMITING; PHASE 3 CLINICAL TRIAL (TOPIC); PRESCRIPTION; QUALITY ADJUSTED LIFE YEAR; REVIEW; RISK BENEFIT ANALYSIS; RISK MANAGEMENT; SINGAPORE; STATISTICAL ANALYSIS; STROKE; SWITZERLAND; TAXONOMY; THORAX DISEASE; UNITED STATES;

EID: 84862062562     PISSN: 17428955     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

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