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Effect of database profile variation on drug safety assessment: an analysis of spontaneous adverse event reports of Japanese cases
BACKGROUND: The use of a statistical approach to analyze cumulative adverse event (AE) reports has been encouraged by regulatory authorities. However, data variations affect statistical analyses (eg, signal detection). Further, differences in regulations, social issues, and health care systems can c...
Gorde:
| Argitaratua izan da: | Drug Des Devel Ther |
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| Egile Nagusiak: | , , , , , , , , |
| Formatua: | Artigo |
| Hizkuntza: | Inglês |
| Argitaratua: |
Dove Medical Press
2015
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| Gaiak: | |
| Sarrera elektronikoa: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4472069/ https://ncbi.nlm.nih.gov/pubmed/26109846 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.2147/DDDT.S81998 |
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