Statistical evaluation and BE hypotheses in full replicate design [RSABE / ABEL]
Dear All,
Is it OK to use the following approach of statistical evaluation in a BE study with full replicate design:
Edit: Category changed; see also this post #1. [Helmut]
Is it OK to use the following approach of statistical evaluation in a BE study with full replicate design:
- Average bioequivalence is used to determine bioequivalence first.
- If bioequivalence is not met for Cmax, scaled-average-bioequivalence can be used if both of the following conditions are met:
- the point estimate of the geometric mean ratio lies within the 80.00-125.00% range;
- the R-R within-subject CV is > 30%, and is not the result of outliers?
- the point estimate of the geometric mean ratio lies within the 80.00-125.00% range;
Edit: Category changed; see also this post #1. [Helmut]
Complete thread:
- Statistical evaluation and BE hypotheses in full replicate designElena777 2020-01-28 07:02 [RSABE / ABEL]
- Inflation of the TIE as well Helmut 2020-01-29 15:38
- Inflation of the TIE as well Elena777 2020-01-29 20:01
- Tricky… Helmut 2020-01-30 12:07
- Tricky… Mikalai 2020-01-30 13:08
- Terrible… Helmut 2020-01-30 15:09
- Flawed evaluation accepted Helmut 2020-01-31 12:19
- Flawed evaluation accepted Mikalai 2020-01-31 12:40
- Flawed evaluation accepted Helmut 2020-01-31 14:17
- Flawed evaluation accepted Mikalai 2020-01-31 16:41
- Flawed approach even if accepted ? Helmut 2020-01-31 20:28
- Flawed approach even if accepted ? Mikalai 2020-02-01 16:18
- misunderstanding mittyri 2020-02-01 21:34
- misunderstanding Mikalai 2020-02-06 13:41
- misunderstanding mittyri 2020-02-06 16:23
- misunderstanding Mikalai 2020-02-06 13:41
- The globe is flat! d_labes 2020-02-05 19:16
- misunderstanding mittyri 2020-02-01 21:34
- Flawed approach even if accepted ? Mikalai 2020-02-01 16:18
- Flawed approach even if accepted ? Helmut 2020-01-31 20:28
- Flawed evaluation accepted Mikalai 2020-01-31 16:41
- Flawed evaluation accepted Helmut 2020-01-31 14:17
- Flawed evaluation accepted Mikalai 2020-01-31 12:40
- Tricky… wienui 2020-01-30 18:53
- Tricky… Helmut 2020-01-30 19:18
- Tricky… wienui 2020-02-03 07:10
- ABE vs. ABEL Helmut 2020-02-03 12:25
- zigzag d_labes 2020-02-05 18:53
- zigzag Helmut 2020-02-05 19:46
- zigzag Mikalai 2020-02-06 11:38
- helter-skelter Helmut 2020-02-06 20:12
- helter-skelter Mikalai 2020-02-10 16:10
- helter-skelter Helmut 2020-02-06 20:12
- zigzag Mikalai 2020-02-06 11:38
- zigzag Helmut 2020-02-05 19:46
- zigzag d_labes 2020-02-05 18:53
- ABE vs. ABEL Helmut 2020-02-03 12:25
- Tricky… wienui 2020-02-03 07:10
- Tricky… Helmut 2020-01-30 19:18
- Tricky… Mikalai 2020-01-30 13:08
- Tricky… Helmut 2020-01-30 12:07
- Inflation of the TIE as well zizou 2020-02-01 17:00
- Inflation of the TIE as well nobody 2020-02-01 23:30
- Inflation of the TIE as well Elena777 2020-03-10 19:28
- Fishing in the dark Helmut 2020-03-10 21:06
- Inflation of the TIE as well Elena777 2020-01-29 20:01
- Statistical evaluation and BE hypotheses in full replicate design nobody 2020-02-03 15:07
- TIE, repeat once more please... Astea 2020-04-02 12:41
- Inflation of the TIE as well Helmut 2020-01-29 15:38