Developing tools for the safety specification in risk management plans: Lessons learned from a pilot project

Pharmacoepidemiology and Drug Safety

Volumn 17, Issue 5, 2008, Pages 445-454

  Cooper, Andrew J P ^a   Lettis, Sally ^a   Chapman, Charlotte L ^a   Evans, Stephen J W ^b   Waller, Patrick C ^c   Shakir, Saad ^c   Payvandi, Nassrin ^a   Murray, Alison B ^a  

^a GLAXOSMITHKLINE   (United Kingdom)

^b LONDON SCHOOL OF HYGIENE AND TROPICAL MEDICINE   (United Kingdom)

^c DRUG SAFETY RESEARCH UNIT   (United Kingdom)

Author keywords

Adverse event; Epidemiology; ICH E2E; Laboratory data; Pharmacovigilance plan; Risk management plan; Safety specification

Indexed keywords

ACNE; ANXIETY DISORDER; ARTICLE; ASTHENIA; BEHAVIOR DISORDER; CLINICAL STUDY; CONFIDENCE INTERVAL; CONTUSION; DEPRESSION; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; EXPERIENCE; FRACTURE; HUMAN; MALAISE; MEDICAL RESEARCH; MENSTRUATION DISORDER; MYALGIA; PRACTICE GUIDELINE; PRIORITY JOURNAL; RISK ASSESSMENT; RISK MANAGEMENT; SENSITIVITY ANALYSIS; SLEEP DISORDER;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CONFIDENCE INTERVALS; CONTROLLED CLINICAL TRIALS AS TOPIC; COOPERATIVE BEHAVIOR; DATA INTERPRETATION, STATISTICAL; EUROPEAN UNION; EVIDENCE-BASED MEDICINE; GUIDELINES AS TOPIC; HUMANS; MARKETING; ODDS RATIO; PILOT PROJECTS; RISK MANAGEMENT; TIME FACTORS;

EID: 44249126472     PISSN: 10538569     EISSN: 10991557     Source Type: Journal    
DOI: 10.1002/pds.1576     Document Type: Article

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