Basic aspects of risk-benefit analysis

Seminars in Thrombosis and Hemostasis

Volumn 25, Issue 1, 1999, Pages 89-96

  Beckmann, Jürgen ^a  

^a Fed Inst Drugs and Med Devices   (Germany)

Author keywords

Adverse drug reaction (ADR); Benefit risk balance; Evidence of benefit and risk; Risk of ADRs

Indexed keywords

ADVERSE DRUG REACTION; ARTICLE; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; EVIDENCE BASED MEDICINE; MEDICAL DECISION MAKING; PRIORITY JOURNAL; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; TECHNIQUE;

EID: 0032937771     PISSN: 00946176     EISSN: None     Source Type: Journal    
DOI: 10.1055/s-2007-996430     Document Type: Article

References (6)

1. 1. Edwards R, Wiholm BE, Martinez C. Concepts in risk-benefit assessment. Drug Safety 1996;15:1-7
2. 2. Report of CIOMS Working Group IV. Benefit-Risk Balance for Marketed Drugs: Evaluating Safely Signals. Geneva: Council for International Organizations of Medical Sciences; 1998
3. 3. Gordon AJ. Implementation and impact of ICH guideline E2A: Definitions and standards for expedited reporting. Proceedings of the Third International Conference on Harmonization. Belfast: Queens University; 1996:461-469
4. 4. WHO Adverse Reaction Terminology - Critical Term List. Uppsala: WHO Collaborating Centre for International Drug Monitoring; 1996
5. 5. Report of CIOMS Working Group III. Guidelines for Preparing Core Clinical-Safety Information on Drugs. Geneva: Council for International Organizations of Medical Sciences; 1995
6. 6. Edwards R, Lindquist M, Wiholm BE, Napke E. Quality criteria for early signals of possible adverse drug reactions. Lancet 1990;336:156-158