Statistical considerations of noninferiority, bioequivalence and equivalence testing in biosimilars studies
In recent years, the development of follow-on biological products (biosimilars) has received increasing attention. The dissertation covers statistical methods related to three topics of Non-inferiority (NI), Bioequivalence (BE) and Equivalence in demonstrating biosimilarity. For NI, one of the key r...
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| Language: | en_US |
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2016
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| Online Access: | https://hdl.handle.net/2144/14243 |