Bioequivalence and Bioavailability Forum

Dear HS,

❝ • PK data for the inactive metabolite, clopidogrel carboxylic acid, should be regarded as supportive only.

Having observed the development of the EU BE-requirements over some years I have the clear impression that the regulators are going in the direction of preferring to think of BE as a quality issue rather than a clinical issue (there pro's and con's for both, I guess) and along with that the regulators seem to adhere more and more rigorously to the formalised requirements, so that they do not need to take decision on basis of judgement (anyone remember the cookbook thread?). If your results are not in accordance with the guidance, if your CI is 0.01 points outside the acceptance limits etc, well, then you do not have an equivalent formulation and your dossier faces rejection with very little opportunity to e.g. discuss clinical relevance and such.

Because of this it is difficult for me to understand what supportive data are or when they become handy or make a difference. In fact I could be afraid we are getting to a point where supportive data could not be used by an applicant to claim BE but could be used by regulators as basis for rejections.

Anyone else been thinking thoughts like this, or am I alone in the universe?


EM.