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Draj86
Draj86
Level II

Between batch Bioequivalence based on between batch variability

Created: Oct 18, 2022 01:05 AM  |  Last Modified: Jun 9, 2023 9:00 AM (1607 views)

Hi guys can any body suggest the path to perform the between batch bio equivalence based on mean difference between reference and test divided by between batch variability.

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Mark_Bailey
Staff Mark_Bailey
Staff

Re: Between batch Bioequivalence based on between batch variability

Oct 19, 2022 09:51 AM (1579 views)  |  Posted in reply to message from Draj86 10-18-2022

You could apply the two one-sided t-tests after you specify the acceptable margin. H0: test < (reference - margin) or (reference + margin) < test. H1: (reference - margin) < test < (reference + margin). Both one-sided tests must be significant to claim equivalence.

 

JMP can perform this test for you in the Oneway platform if you have the data, not the summary statistics.

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