Potency correction - Example [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2018-06-24 14:40 (1505 d 12:47 ago) – Posting: # 18956
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Dear ElMaestro,

as said in my post above the potency correction was abondoned in my company since 2010 so I couln't give a real example, but only a fictional.

Where I came across with potency correction last times was the case for OIPs.
Here the potency correction was applied based on the fine particle content of a distinct fraction of the fine particles, chosen based on correlation with the PK metrics.
IMHO this was really "gymnastics on numbers".

But at end of the day the sponsor is right.
And as far as I know the regulatory agency / agencies accepted that to a certain extent.

That example directs toward your opinion
» Anyhow, the intention with section 4.1.8, I think, was to pave the way forward for a case where e.g. the Test has a potency of 104% and the Ref has a potency of 95% of the (identical) label claim etc.



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