Potency correction - EAUnion opinion [Regulatives / Guidelines]

posted by mittyri – Russia, 2018-06-23 22:53 (1222 d 07:23 ago) – Posting: # 18953
Views: 4,713

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.
:confused::-D
Why bother? Just close that backdoor :cool:

Kind regards,
Mittyri

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