Confidence interval between two study for same test and reference lot [Study As­sess­ment]

posted by RahulG628 – India, 2021-08-04 17:40 (327 d 12:07 ago) – Posting: # 22506
Views: 1,919

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

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