Bioequivalence and Bioavailability Forum

Good point, DLabes.
First: "In studies to determine bioequivalence after a single dose, AUC_t, AUC_oo, C_max and t_max should be determined."
And then later:
"The assessment of bioequivalence is based upon 90% confidence intervals for the ratio of the population geometric means (test/reference) for the parameters under consideration."
One could get the impression that the pharmacokinetolophystic subgroup is requesting a parametric analysis of t_max including 90% CI's and the works, had it not been for the final punch:
"In studies to determine bioequivalence after a single dose, the parameters to be analysed are AUC_t and C_max."
...so why do they want t_max at all?

EM.

Dear DLabes,

yes, it’s unbelievable. It took these gurus 14 months (and 11 internal drafts) since the 'Recommendation on the Need for Revision of NfG on BA/BE' to come up with this…

The second paragraph of ‘Statistical analysis’ (lines 500-505) with respect to t_max is bullshit anyhow. If I read it as a ‘cookbook’ (as intended by the authors) does it mean I should not only use a parametric method, but also log-transform data from a discrete sampling distribution?

This is a major statistical flaw.
If engineers in the aerospace industry dealing with rare events would apply statistical methods based on the Gaussian rather the Poisson distribution we would see quite a lot of plane accidents caused by wrong specs of mechanical/electrical/electronic devices.

After a quick look I only liked this one (lines 514-516):

‘A test for carry-over should not be performed and no decisions regarding the analysis (e.g. analysis of the first period, only) should be made on the basis of such a test.’

I’ll be opening a new thread collecting a critical review anyhow.