Potency correction - EAUnion opinion [Regulatives / Guidelines]

posted by mittyri – Russia, 2018-06-23 22:53 (885 d 22:27 ago) – Posting: # 18953
Views: 4,058

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

Complete thread:

Activity
 Admin contact
21,210 posts in 4,426 threads, 1,481 registered users;
online 5 (0 registered, 5 guests [including 5 identified bots]).
Forum time: Wednesday 20:21 CET (Europe/Vienna)

You can’t fix by analysis
what you bungled by design.    Richard J. Light, Judith D. Singer, John B. Willett

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