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RegisterPotency correction - EAUnion opinion [Regulatives / Guidelines]
Hi ElMaestro,
I don't have any experience of using that workaround and I bet noone has in Russia.
BTW I compared 'the gold standard' EMA Guideline and EAUnion Guideline.
(note that sections 4.1.2 and relevant in EAUnion GL are pretty similar)
EMA:
4.1.8 In bioequivalence studies, the pharmacokinetic parameters should in general not be adjusted for differences in assayed content of the test and reference batch. 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.
EAUnion:
72 In bioequivalence studies, the pharmacokinetic parameters should in general not be adjusted for differences in assayed content of the test and reference batch. However, in exceptional cases where a reference batch with an assay content differs less than 5% from test product (in accordance with subsection 2 of current section) content correction could be accepted.
Why bother? Just close that backdoor
I don't have any experience of using that workaround and I bet noone has in Russia.
BTW I compared 'the gold standard' EMA Guideline and EAUnion Guideline.
(note that sections 4.1.2 and relevant in EAUnion GL are pretty similar)
EMA:
4.1.8 In bioequivalence studies, the pharmacokinetic parameters should in general not be adjusted for differences in assayed content of the test and reference batch. 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.
EAUnion:
72 In bioequivalence studies, the pharmacokinetic parameters should in general not be adjusted for differences in assayed content of the test and reference batch. However, in exceptional cases where a reference batch with an assay content differs less than 5% from test product (in accordance with subsection 2 of current section) content correction could be accepted.
Why bother? Just close that backdoor
—
Kind regards,
Mittyri
Kind regards,
Mittyri
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 - Example d_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 opinionmittyri 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