Let me answer my own question [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2018-06-25 16:24 (884 d 03:33 ago) – Posting: # 18960
Views: 3,707

Thanks all,

Lots of good input in this thread.
Here's my own view. Bear in mind this was a question about assumptions.

In average BE we test if T and R on average do the same.
If we apply the potency correction to average BE then it will work if we are willing to test if if an average (or median or typical) batch of T and an average (or median or typical) batch of R R on average do the same, given that we may be dealing with an non-average (non-median, atypical) batch of R.
However, bear in mind the condition "where a reference batch with an assay content differing less than 5% from test product cannot be found" implies that the applicant is in no position to argue anything about the chosen batch being atypical, non-average, non-median. On top of that (4.1.2) "The Applicant should document how a representative batch of the reference product with regards to dissolution and assay content has been selected."

There you have the implied/implicit assumption (in bold above) for potency correction to work. And you have my opinion why it is a dead end until someone gives me a very good reason to think otherwise.
In this regard I will retain the privilege of defining what very good means. I do not have a protocol for it in which I can pre-specify it. :-)

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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