qualityassurance
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2026-01-16 13:52
(138 d 18:01 ago)

Posting: # 24547
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 Repeat BE only for failed analyte [Study As­sess­ment]

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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
 
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