| アブストラクト | BACKGROUND: As of 2014, the US FDA was considering policy options to promote accurate attribution of adverse events for biosimilars. In order to assess the identification and traceability of biologics from multiple sources, Tufts University's Center for the Study of Drug Development conducted a study reviewing the current FDA Adverse Event Reporting System (FAERS) for reports related to insulin and growth hormone products. METHODS: For this study, all primary suspect reports that were received by FAERS for human growth hormone (hGH) and human insulin between the fourth quarter of 2005 and the third quarter of 2013 were extracted and analyzed. RESULTS: The rates of "accurate" brand (ie, identifiable) drug names were generally high, with a higher incidence for hGH drugs than for insulin drugs (92% of hGH primary suspect reports vs 84% of insulin primary suspect reports). Lot number completion rates were generally low, with a higher incidence for insulin drugs than for hGH drugs (37% of insulin primary suspect reports vs 13% of hGH primary suspect reports). There were 13.5% of insulin reports that could not be linked to manufacturers, while 7.5% of hGH reports could not be linked to a manufacturer. CONCLUSIONS: The completion and accuracy rates of FAERS data on biologics observed in this study are consistent with those observed in earlier studies and suggest that traceability in adverse event reports can be improved through more consistent use of brand names or other product specific identifiers and through more frequent inclusion of lot numbers. |
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| ジャーナル名 | Therapeutic innovation & regulatory science |
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| 投稿日 | 2015/9/1 |
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| 投稿者 | Stergiopoulos, Stella; Brown, Carrie A; Grampp, Gustavo; Felix, Thomas; Getz, Kenneth A |
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| 組織名 | 1 Tufts University, Boston, MA, USA.;2 Amgen Inc, Thousand Oaks, CA, USA. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/30227042/ |
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