Bioequivalence and Bioavailability Forum

Hi Ben,

❝ […] I am actually excited to have some kind of insights of the results.

❝ Will you present this at some point in time?

I will write a paper on it. What I have so far over there. The survey started last Saturday; six respondents as of today.

❝ ❝ Do you assess models recommended by the FDA?

❝ ❝ ...

❝ ❝ Do you follow the decision scheme recommended by the FDA?

❝ ❝ ...

❝

❝ Maybe I completely missed it, but I couldn't find those recommendations in the guidances.

Stop searching. Nothing specific about multigroup studies in the FDA’s 2001 biostats guidance.

❝ Is there a reference, would you be so kind and share it if possible?

See f.i. here or there. You may find some deficiency letters by the FDA with the same wording on the net. this:
"Group-by-treatment interaction" FDA filetype:pdf

Model 1, testing of the G×T term at the 0.1 level and dropping if n.s. (⇒ Model 2) is described by Bolton and Bon.*

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• Bolton S, Bon C. Pharmaceutical Statistics. Practical and Clinical Applications. New York: informa healthcare; Fifth edition 2009. p. 629.