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RegisterThe unknown EMA [Regulatives / Guidelines]
Dear Jaime, dear Amr!
The EMA guideline states in Section 4.1.8 Evaluation, page 13/27:
"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. If content correction is to be used, this should be pre-specified in the protocol and justified by inclusion of the results from the assay of the test and reference products in the protocol."
(Emphases by me)
❝ I don't know of any current guideline allowing for a potency correction...
The EMA guideline states in Section 4.1.8 Evaluation, page 13/27:
"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. If content correction is to be used, this should be pre-specified in the protocol and justified by inclusion of the results from the assay of the test and reference products in the protocol."
(Emphases by me)
—
Regards,
Detlew
Regards,
Detlew
Complete thread:
- BE Information Request A-M-R 2011-01-23 08:40
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Potency correction Jaime_R 2011-01-23 14:44
- The unknown EMAd_labes 2011-01-24 08:19
- The unknown EMA Jaime_R 2011-01-24 10:52
- The unknown EMA ElMaestro 2011-01-24 13:22
- The unknown EMAd_labes 2011-01-24 08:19
- Potency correction Jaime_R 2011-01-23 14:44
Ing. Helmut Schütz