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RegisterConfidence interval between two study for same test and reference lot [Study Assessment]
Dear Helmut,
Thank you for allowing me to join forum.
Need your opinion on following point.
We conducted two BE study for one of the ANDA, in one study we got 90% CI (77-108) and another study we got (106-125.8) for same test and RLD lot. Will it possible to combine both study two justify product is bio-equivalent based on observe variability for regulatory submissions.
Thanks & Regards,
Rahul
Thank you for allowing me to join forum.
Need your opinion on following point.
We conducted two BE study for one of the ANDA, in one study we got 90% CI (77-108) and another study we got (106-125.8) for same test and RLD lot. Will it possible to combine both study two justify product is bio-equivalent based on observe variability for regulatory submissions.
Thanks & Regards,
Rahul
Complete thread:
- Confidence interval between two study for same test and reference lotRahulG628 2021-08-04 17:40 [Study Assessment]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different PE in repeated study Helmut 2021-08-04 21:03
- Confidence interval between two study for same test and reference lot ElMaestro 2021-08-04 21:41
Ing. Helmut Schütz