A Comprehensive Approach to Benefit-Risk Assessment in Drug Development

Basic and Clinical Pharmacology and Toxicology

Volumn 111, Issue 1, 2012, Pages 65-72

  Sarac, Sinan B ^a,b   Rasmussen, Christian H ^a,b   Rasmussen, Morten A ^c   Hallgreen, Christine E ^a   Søeborg, Tue ^d   Colding Jørgensen, Morten ^a   Christensen, Per K ^a   Thirstrup, Steffen ^d   Mosekilde, Erik ^b  

^a NOVO NORDISK A S   (Denmark)

^b TECHNICAL UNIVERSITY OF DENMARK   (Denmark)

^c UNIVERSITY OF COPENHAGEN   (Denmark)

^d DANISH MEDICINES AGENCY   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CLINICAL DEVELOPMENT PLAN; CONTROLLED STUDY; DRUG APPROVAL; DRUG MARKETING; DRUG SYNTHESIS; PRIORITY JOURNAL; RISK BENEFIT ANALYSIS; SCORING SYSTEM;

DRUG APPROVAL; HUMANS; PHARMACEUTICAL PREPARATIONS; RISK ASSESSMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84862669055     PISSN: 17427835     EISSN: 17427843     Source Type: Journal    
DOI: 10.1111/j.1742-7843.2012.00871.x     Document Type: Article

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