Inflation of the TIE as well [RSABE / ABEL]

posted by Helmut Homepage – Vienna, Austria, 2020-01-29 15:38 2a02:8388:6bc2:ce80:9d2:542b:2198:e942 – Posting: # 21095
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Hi Elena,

you are modifying the common decision scheme. Why?
Since you are making essentially the same decisions though in a different order, you gain nothing.

» And another question: is this obligatory to include the detailed description of null and alternative hypotheses for Cmax (ABEL) and AUCt (ABE) together with description of conditions that lead to acceptance/rejection of a hypothesis in a protocol of a full replicate study?

Well, that’s the problem with ABEL (and the FDA’s RSABE as well). There is no Null Hypothesis. Before you assess the data you have no clue which path(s) of the framework you will follow. You can – and should – only describe the procedure.

Cheers,
Helmut Schütz
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