Statistical considerations regarding correlated lots in analytical biosimilar equivalence test.


In the evaluation of the analytical similarity data, an equivalence testing approach for most critical and quantitative quality attributes, which are assigned to Tier 1 in their proposed three-tier approach, was proposed. The Food and Drug Administration (FDA) has recommended the proposed equivalence testing approach to sponsors through meeting comments for… (More)
DOI: 10.1080/10543406.2016.1265541


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