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Dhruv Shah ☆ India, 2015-09-28 13:08 (3924 d 17:30 ago) Posting: # 15476 Views: 7,154 |
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I just want to know that for RSABE study in addition to having a point estimate in between 80-125, do we need to calculate the 90% CI limits as we do in ABE study? (Is there a regulatory requirement?) Moreover in order to establish BE, the 95% upper confidence bound must be less than or equal to 0. How it is calculated based on the BE outcomes and in simple term what does it mean? i.e what it means if the value is less than or equal to 0 and greater than 0. Regards, Dhruv Shah |
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jag009 ★★★ NJ, 2015-10-01 15:57 (3921 d 14:41 ago) @ Dhruv Shah Posting: # 15510 Views: 5,229 |
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❝ I just want to know that for RSABE study in addition to having a point estimate in between 80-125, do we need to calculate the 90% CI limits as we do in ABE study? (Is there a regulatory requirement?) Please re-read the guidance. John |
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d_labes ★★★ Berlin, Germany, 2015-10-01 18:23 (3921 d 12:15 ago) @ Dhruv Shah Posting: # 15511 Views: 5,342 |
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Dear Druv, additionally to John's suggestion I recommend you Helmut's lectures. There is one with special focus to RSABE / scaled ABEL. Edit: F.i. Reference-Scaled Average Bioequivalence (HVDs/HVDPs), Mumbai, January 2013. [Helmut] — Regards, Detlew |
Ing. Helmut Schütz