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RegisterIbuprofen product-specific bioequivalence guidance EMA [Regulatives / Guidelines]
Dear Forum members,
The question is related to product-specific bioequivalence guidance (EMA) for Ibuprofen draft and Final.
The former indicates that the method should be enantioselective and the later indicates the opposite. Of course we should consider the final guidance and not the draft.
However, all conditions are fulfilled for (⇒ chiral analytics) and also found some public assessment report where chiral method was used and Pharmacokinetic data were submitted for both enantiomers.
Please suggest, whether we should go for chiral or achiral assay?
Thank you.
The question is related to product-specific bioequivalence guidance (EMA) for Ibuprofen draft and Final.
The former indicates that the method should be enantioselective and the later indicates the opposite. Of course we should consider the final guidance and not the draft.
However, all conditions are fulfilled for (⇒ chiral analytics) and also found some public assessment report where chiral method was used and Pharmacokinetic data were submitted for both enantiomers.
Please suggest, whether we should go for chiral or achiral assay?
Thank you.
Complete thread:
- Ibuprofen product-specific bioequivalence guidance EMAqualityassurance 2021-09-26 07:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Ibuprofen product-specific bioequivalence guidance EMA dshah 2021-09-27 10:22
- Undeliverable e-mail Helmut 2021-09-27 14:52
- Enantioselective assay – really? Helmut 2021-09-27 15:55
- Enantioselective assay – really? qualityassurance 2021-10-12 15:15
Ing. Helmut Schütz