Strategy to equivalence testing for development and scale up of biopharmaceutical downstream processes

Chemical Engineering Science(2021)

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摘要
•Equivalence tests assess changes in product quality of biopharmaceutical processes.•Test performance is influenced by the groups' sample sizes, standard deviations and distributions.•Data should be investigated for possible outliers before applying an equivalence test.•A sample size of 4 leads to a significantly higher test performance compared to 3.
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EAC,eac.3sd,eac.Limentani,eac.Tol,ECDF,Fig.,HTS,nr.configs,p-val,sd,Supp.Table,TOST
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