The FDA’s fourth BE approach! [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2015-09-22 15:25 (3434 d 18:47 ago) – Posting: # 15443
Views: 17,195

Hi nobody,

❝ Please elucidate the scientific background for the "upper limit of the 90% confidence interval for the test-to-reference ratio of the within-subject variability should be ≤ 2.5" of FDA dabigatran BE guidance


As if pulling a rabbit out of the hat. László Endrényi regularly goes ballistic on this issue. He showed already twenty years ago (in the context of IBE) that this limit is arbitrary and the “method” flawed.

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