Is there a need for a universal benefit-risk assessment framework for medicines? Regulatory and industry perspectives

Pharmacoepidemiology and Drug Safety

Volumn 22, Issue 9, 2013, Pages 1004-1012

  Leong, James ^a   Mcauslane, Neil ^b   Walker, Stuart ^a,b   Salek, Sam ^a  

^a CARDIFF UNIVERSITY   (United Kingdom)

^b Centre for Innovation in Regulatory Science   (United Kingdom)

Author keywords

Benefit risk assessment; Benefit risk methodologies; Framework; Pharmaceutical industry; Pharmacoepidemiology; Regulatory agency; Universal

Indexed keywords

ARTICLE; DECISION MAKING; DRUG INDUSTRY; DRUG LEGISLATION; INTERPERSONAL COMMUNICATION; LIFE CYCLE; PHARMACOEPIDEMIOLOGY; PRIORITY JOURNAL; QUESTIONNAIRE; RISK ASSESSMENT; STATISTICS;

BENEFIT-RISK ASSESSMENT; BENEFIT-RISK METHODOLOGIES; FRAMEWORK; PHARMACEUTICAL INDUSTRY; PHARMACOEPIDEMIOLOGY; REGULATORY AGENCY; UNIVERSAL;

DECISION SUPPORT TECHNIQUES; DECISION TREES; DRUG INDUSTRY; DRUG-RELATED SIDE EFFECTS AND ADVERSE REACTIONS; EVIDENCE-BASED MEDICINE; GOVERNMENT REGULATION; LEGISLATION, DRUG; MODELS, THEORETICAL; NATIONAL HEALTH PROGRAMS; PHARMACEUTICAL PREPARATIONS; PRODUCT SURVEILLANCE, POSTMARKETING; RISK ASSESSMENT;

EID: 84882713601     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.3464     Document Type: Article

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