Potency correction - Example [Regulatives / Guidelines]

posted by d_labes  – Berlin, Germany, 2018-06-24 16:40 (2105 d 00:49 ago) – Posting: # 18956
Views: 5,438

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.


Regards,

Detlew

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
95 visitors (0 registered, 95 guests [including 9 identified bots]).
Forum time: 16:30 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5