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- W1523567531 abstract "Biologic therapies are derived from living cells through recombinant DNA technology. Pharmacovigilance for biologics, compared with that for small molecules, is largely focused on adverse events related to on-target effects. Noninterventional pharmacoepidemiologic research plays an important role in the investigation of known and unanticipated adverse events that may arise following exposure to these novel therapies in routine clinical practice. In this chapter, we consider studies related to four biologic therapies: Epogen®, Enbrel®, Prolia®, and XGEVA®. We discuss key planning and analysis concepts that facilitate valid assessment of long-term safety of these biologic therapies. While such studies are vulnerable to uncontrolled bias, they can often provide strong evidence about the presence or absence of appreciable risks to patients in real-world clinical practice that would be difficult or impossible to obtain from interventional studies." @default.
- W1523567531 created "2016-06-24" @default.
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- W1523567531 date "2014-04-01" @default.
- W1523567531 modified "2023-09-27" @default.
- W1523567531 title "Pharmacoepidemiology as Part of Pharmacovigilance for Biologic Therapies" @default.
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- W1523567531 doi "https://doi.org/10.1002/9781118820186.ch44" @default.
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