Potency correction - Only in exceptional cases [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2018-06-23 20:04 (1996 d 21:48 ago) – Posting: # 18951
Views: 5,307

Dear ElMaestro,

❝ section 4.1.8 of the EMA guideline opens up for potency calculation for BE evaluation.

❝ ...

read the Section again. It states unambigously:
"In bioequivalence studies, the pharmacokinetic parameters should in general not be adjusted for differences in assayed content of the test and reference batch."

That was the policy which my former company followed over years. Ended with the publication of the 2010 guideline.
This is indeed

❝ ... 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 reading the next sentence:
"However, in exceptional cases where a reference batch with an assay content differing less than 5% from test product cannot be found (see section 4.1.2) content correction could be accepted ..."
Emphasis by me.

❝ I still can't [...] see in which way that opportunity does anything good for the sake of the EU patient.

Imagine for example there is no reference product of 50 µg content, no one produces the 50 µg formulation any longer, but only one with 60 µg. And the patient is optimally prescribed a dose of 50 µg. Having such a formulation with 50 µg is a benefit for the patient, I think.



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