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RegisterRepeat BE only for failed analyte [Study Assessment]
Hello Experts,
We have conducted BE of modified release fixed dose combination product. BE is successful for analyte-A while failing in AUCinf on a border line due to one outlier subject for analyte-B. Since our study is successful for analyte-A, is it possible that in new study (without change in formulation) we only analyse analyte-B and prove BE for analyte-b only. Will it be acceptable to regulatory authority such as EMA?
Any one has applied this approach in past and was it accepted by regulatory authorities?
Regards,
QA
We have conducted BE of modified release fixed dose combination product. BE is successful for analyte-A while failing in AUCinf on a border line due to one outlier subject for analyte-B. Since our study is successful for analyte-A, is it possible that in new study (without change in formulation) we only analyse analyte-B and prove BE for analyte-b only. Will it be acceptable to regulatory authority such as EMA?
Any one has applied this approach in past and was it accepted by regulatory authorities?
Regards,
QA
Complete thread:
- Repeat BE only for failed analytequalityassurance 2026-01-16 12:52
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Ing. Helmut Schütz