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RegisterPotency correction - Example [Regulatives / Guidelines]
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
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
Regards,
Detlew
Complete thread:
- Potency correction - I still don't get it ElMaestro 2018-06-23 10:14 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Potency correction - Only in exceptional cases d_labes 2018-06-23 18:04
- Potency correction - Only in exceptional cases ElMaestro 2018-06-23 19:55
- Potency correction: Rather why than when Helmut 2018-06-24 00:55
- Potency correction: Rather why than when ElMaestro 2018-06-25 10:22
- Potency correction: Upper limit? Helmut 2018-06-25 15:34
- Potency correction: Rather why than when ElMaestro 2018-06-25 10:22
- Potency correction - Exampled_labes 2018-06-24 14:40
- Potency correction: Rather why than when Helmut 2018-06-24 00:55
- Potency correction - Only in exceptional cases ElMaestro 2018-06-23 19:55
- Potency correction - EAUnion opinion mittyri 2018-06-23 22:53
- Potency correction - example Ohlbe 2018-06-25 10:10
- Let me answer my own question ElMaestro 2018-06-25 18:24
- Someone, somebody - slightly OT d_labes 2018-06-25 19:49
- Potency correction - Only in exceptional cases d_labes 2018-06-23 18:04
Ing. Helmut Schütz