Document Detail

Risk/benefit evaluation of drugs: the role of the pharmaceutical industry in Germany.
MedLine Citation:
PMID:  11867924     Owner:  NLM     Status:  MEDLINE    
Drugs that are efficacious have usually also undesired side effects. When applying for marketing authorization of a drug, demonstration of a positive risk/benefit ratio is a prerequisite for approval by the competent authorities. Once on the market, risk/benefit evaluation has to be continued in order to determine whether the risk/benefit ratio is still positive or not. The German Drug Law, by means of article 5, poses this responsibility on the pharmaceutical entrepreneur. Specific instructions on how to perform the risk/benefit evaluation can be derived from article 5, and a decision matrix was developed to support taking action if the risk/benefit ratio has changed. Historical and current examples are presented to illustrate changes of the risk/benefit ratio, problems associated with detecting risk signals, and the resulting regulatory actions.
R Schosser
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Publication Detail:
Type:  Journal Article; Review    
Journal Detail:
Title:  European surgical research. Europäische chirurgische Forschung. Recherches chirurgicales européennes     Volume:  34     ISSN:  0014-312X     ISO Abbreviation:  Eur Surg Res     Publication Date:    2002 Jan-Apr
Date Detail:
Created Date:  2002-02-27     Completed Date:  2002-08-28     Revised Date:  2006-11-30    
Medline Journal Info:
Nlm Unique ID:  0174752     Medline TA:  Eur Surg Res     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  203-7     Citation Subset:  IM    
Copyright Information:
Copyright 2002 S. Karger AG, Basel
Medical Affairs, BioScience Division, Baxter Deutschland GmbH, Heidelberg, Germany.
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MeSH Terms
Drug Industry / legislation & jurisprudence*,  standards*
Drug Monitoring / standards
Risk Assessment*

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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