Potency correction - I still don't get it [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2018-06-23 10:14 (886 d 10:38 ago) – Posting: # 18950
Views: 4,327

Hi all,

section 4.1.8 of the EMA guideline opens up for potency calculation for BE evaluation.
I can see what it does. I still can't, after having read up on this for 8 years, see in which way that opportunity does anything good for the sake of the EU patient.

Can somebody give me a numerical example illustrating why potency correction is to the advantage of not only the Sponsor but also the patient??
90% CI is 77-108, but if assays differ, then we divide and multiply and do some gymnastics on the numbers, and hey presto we now have an approvable product. Nice for Sponsor (or at least the guy in the Armani suit). But is that really advantageous for the Patient? It may be if we seriously play around with the definition of average bioequivalence. Let me hear your thoughts, please: Under which assumptions in your opinion will a potency correction help regulators decide on relative rate and extent of absorption, and how does this (these) assumption(s) fit into your understanding of average BE?

Many thanks.

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.

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