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pro vyhledávání: '"Meiyu Shen"'
Publikováno v:
Journal of Biopharmaceutical Statistics. 29:1068-1081
For the reference scaled equivalence hypothesis to reduce the deficiency of the current practice in analytical equivalence assessment, the Wald test with Constrained Maximum Likelihood Estimate (CMLE) of the standard error was proposed to improve the
Publikováno v:
Journal of Biopharmaceutical Statistics. 27:197-205
To evaluate the analytical similarity between the proposed biosimilar product and the US-licensed reference product, a working group at Food and Drug Administration (FDA) developed a tiered approach. This proposed tiered approach starts with a critic
Publikováno v:
Journal of Biopharmaceutical Statistics. 27:213-219
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 Administra
Autor:
Lixin Leo Xu, Meiyu Shen
Publikováno v:
Bioanalysis. 9(8)