Bioequivalence and Bioavailability Forum

Hi Mittyri,

❝ may be someone can shed some light on the current status of guideline on quality and equivalence of topical products in EMA jurisdiction?

Not me.

❝ The consultation period is over more than 5 years ago and no updates on EMA site so far.

Well, some of the FDA’s guidances are in draft state for 20 years…

❝ Citing a paper with experts:

❝ ❝ […] it could be convenient to widen the acceptance range according to the observed variability in the reference product.

Already proposed in the draft, lines 708–715:

The acceptance criteria for equivalence parameters is that the 90% confidence interval for the ratio of means of the test and comparator products should be contained within the acceptance interval of 80.00 – 125.00%, unless justified.
Wider acceptance criteria for the 90% confidence interval, to a maximum of 69.84 – 143.19, may be accepted in the case of high within-subject or within-donor variability observed with low strength and imited diffusion drug products, and if clinically justified. The procedure in the Guideline on Investigation of Bioequivalence, “Section 4.1.10 Highly variable drugs or drug products” should be followed.

❝ Everything is good to go, little amendments required. So what?

Obviously the MWP (successor of the PKWP) has other priorities.