| Risk/benefit evaluation of drugs: the role of the pharmaceutical industry in Germany. | |
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MedLine Citation:
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PMID: 11867924 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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R Schosser |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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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:
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Created Date: 2002-02-27 Completed Date: 2002-08-28 Revised Date: 2006-11-30 |
Medline Journal Info:
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Nlm Unique ID: 0174752 Medline TA: Eur Surg Res Country: Switzerland |
Other Details:
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Languages: eng Pagination: 203-7 Citation Subset: IM |
Copyright Information:
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Copyright 2002 S. Karger AG, Basel |
Affiliation:
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Medical Affairs, BioScience Division, Baxter Deutschland GmbH, Heidelberg, Germany. rudolh_schosser@baxter.com |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Drug Industry
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legislation & jurisprudence*,
standards* Drug Monitoring / standards Germany Humans Risk Assessment* |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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