Bioequivalence and Bioavailability Forum

Hi ElMaestro,

❝ ❝ What on earth gives you this impression? I’m talking about ABE (Stats guidance Appendix E, Progesterone guidance page 8, ANDA guidance page 29):

❝

❝ Wow, that is actually right.

❝ Page 27: "PROC GLM should be used for partially replicate (3-way) BE studies"

And Page 32:

• PROC MIXED should be used for fully replicate (4-way) BE studies

Only the knows why.

❝ Page 29: "For PK parameters with a s_WR < 0.294, use the unscaled average BE approach." (which implies PROC MIXED in their code)

Now you got it. Some stuff there.

❝ So, we must start to work out s_WR using the equations.

Yep. At least that’s easy.

❝ Once we got it, we know whether we need a mixed model or not for the evaluation of BE. We may need the mixed model for one metric, like AUCt and AUCinf, and the equations (ref scaled ABE) for another, like Cmax.

Correct.

❝ I guess this is also the gist of the decision tree you gave. I wonder if this is truly their intention.

That’s the interpretation of all authors who assessed the Type I Error. Sent you Mehl.

❝ The mixed model therefore seems to have been saved by the bell.

?

❝ This really emphasizes the need for a CI solution that allows V estimated without the existence of Z and R separately.

Happy that finally I conveyed the message.

❝ I am curious now - we should make a little study on the type I error in case of missing ref values.

Oh dear, reaching for the stars! So far we have no clue how to come up with a solution for complete data. Appetizer.
Since there were comments on about study costs, see there.