| Guiding principles of safety as a basis for developing a pharmaceutical safety culture. | |
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MedLine Citation:
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PMID: 18690959 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Despite the best efforts of industry and regulatory authorities, the trust of society in the process of medicine development and communication of pharmaceutical risk has ebbed away. In response the US government has called for a culture of compliance while the EU regulators talk of a 'culture of scientific excellence'. However, one of the fundamental problems hindering progress to rebuilding trust based on a pharmaceutical safety culture is the lack of agreement and transparency between all stakeholders as to what is meant by a 'Safety of Medicines'. For that reason, we propose 'Guiding Principles of Safety for Pharmaceuticals' are developed analogous to the way that Chemical Safety has been tackled. A logical starting point would be to examine the Principles outlined by the US Institute of Medicine although we acknowledge that these Principles require further extensive debate and definition. Nevertheless, the Principles should take centre stage in the reform of pharmaceutical development required to restore society's trust. |
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Authors:
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Brian Edwards; Axel K Olsen; Matthew D Whalen; Marla J Gold |
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Publication Detail:
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Type: Journal Article; Review |
Journal Detail:
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Title: Current drug safety Volume: 2 ISSN: 1574-8863 ISO Abbreviation: - Publication Date: 2007 May |
Date Detail:
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Created Date: 2008-08-11 Completed Date: 2008-09-03 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101270895 Medline TA: Curr Drug Saf Country: Unknown |
Other Details:
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Languages: eng Pagination: 135-9 Citation Subset: IM |
Affiliation:
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Benefit Risk Management, Division of Janssen Cilag, UK. BEdwards@brmgb.JNJ.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Goals Humans Legislation, Drug Organizational Culture* Organizational Innovation Pharmaceutical Preparations / adverse effects* Safety / legislation & jurisprudence, standards* |
| Chemical | |
Reg. No./Substance:
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0/Pharmaceutical Preparations |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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