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- W2110463485 abstract "With NHS budgets under increasing pressure, generics and biosimilars help control spiralling prescribing costs. So, nurses should consider prescribing generically whenever clinically appropriate. However, this article suggests that the pharmacokinetic rationale underpinning generic substitution and the subtle, but potentially clinically significant, differences in some biosimilars underscore the importance of brand name prescribing in certain circumstances. Regulatory authorities approve generics and biosimilars based, partly, on equivalence studies. As developing more effective pharmaceuticals becomes increasingly difficult, some new products rely predominately on associated benefits to differentiate the brand from the competition. This shift in emphasis, as well as commercial considerations, encouraged an increase in the number of non-inferiority and equivalence studies. However, these raise ethical and practical concerns compared with classic superiority trials. This feature introduces non-inferiority ..." @default.
- W2110463485 created "2016-06-24" @default.
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- W2110463485 date "2009-01-01" @default.
- W2110463485 modified "2023-09-26" @default.
- W2110463485 title "Equivalence studies: the devil’s in the details" @default.
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- W2110463485 doi "https://doi.org/10.12968/npre.2009.7.1.38631" @default.
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