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Distinguishing hazards and harms, adverse drug effects and adverse drug reactions : implications for drug development, clinical trials, pharmacovigilance, biomarkers, and monitoring.

Abstract:

The terms 'adverse drug effects' and 'adverse drug reactions' are commonly used interchangeably, but they have different implications. Adverse drug reactions arise when a compound (e.g. a drug or metabolite, a contaminant or adulterant) is distributed in the same place as a body tissue (e.g. a receptor, enzyme, or ion channel), and the encounter results in an adverse effect (a physiological or pathological change), which results in a clinically appreciable adverse reaction. Both the adverse e...

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Publication status:
Published

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Publisher copy:
10.1007/s40264-013-0019-9

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Institution:
University of Oxford
Department:
Oxford, MSD, Primary Care Health Sciences, PHC-Seniors
Role:
Author
Journal:
Drug safety
Volume:
36
Issue:
3
Pages:
147-153
Publication date:
2013-03-05
DOI:
ISSN:
0114-5916
URN:
uuid:7d498a48-6821-4bdd-9eff-2614e9c84270
Source identifiers:
387149
Local pid:
pubs:387149

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