Subjects in replicate BE study EU [RSABE / ABEL]
Dear Relaxation and all,
Your suggestions seems very interesting!
I'm not sure that the subjects without T vs R comparison should be included in the analysis according to the EMA GL:
[…] subjects in a crossover trial who do not provide evaluable data for both of the test and reference products […] should not be included.
Also see this post
Your suggestions seems very interesting!
❝ even subjects without data for a T vs R comparison have an impact
I'm not sure that the subjects without T vs R comparison should be included in the analysis according to the EMA GL:
[…] subjects in a crossover trial who do not provide evaluable data for both of the test and reference products […] should not be included.
Also see this post
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Statistical Analysis section of partial replicate BE study cher0424 2015-01-07 06:39 [RSABE / ABEL]
- Subjects to be considered in partial replicate BE study d_labes 2015-01-07 14:45
- Subjects to be considered in partial replicate BE study cher0424 2015-01-07 15:35
- Subjects to be considered in partial replicate BE study cher0424 2015-01-08 06:28
- Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:03
- Subjects to be considered in partial replicate BE study cher0424 2015-01-08 09:51
- Subjects to be considered in partial replicate BE study d_labes 2015-01-08 10:27
- Subjects in replicate BE study EU/FDA Shuanghe 2015-01-08 11:08
- Subjects in replicate BE study EU/FDA cher0424 2015-01-08 13:56
- Subjects in replicate BE study EU/FDA Relaxation 2015-03-02 09:46
- Subjects in replicate BE study EU/FDA d_labes 2015-03-02 11:38
- Subjects in replicate BE study EUmittyri 2015-03-19 20:12
- Subjects in replicate BE study EU/FDA Shuanghe 2015-01-08 11:08
- Subjects to be considered in partial replicate BE study d_labes 2015-01-08 10:27
- Subjects to be considered in partial replicate BE study cher0424 2015-01-08 09:51
- Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:03
- Subjects to be considered in partial replicate BE study Dr_Dan 2015-01-08 08:59
- Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:04
- Subjects to be considered in partial replicate BE study Astea 2015-03-01 18:12
- Subjects to be considered in partial replicate BE study yjlee168 2015-03-01 19:01
- Subjects to be considered in partial replicate BE study Astea 2015-03-09 14:43
- NCA with bear? yjlee168 2015-03-09 15:24
- Bear and null PK parameters mittyri 2015-03-25 09:50
- to exclude or not to exclude the subjects with bear? yjlee168 2015-03-28 21:03
- to exclude or not to exclude - let the user decide mittyri 2015-03-29 19:04
- to exclude or not to exclude - let the user decide yjlee168 2015-03-30 11:28
- to exclude or not to exclude - let the user decide ElMaestro 2015-03-30 15:44
- to exclude or not to exclude - let the user decide yjlee168 2015-03-31 11:15
- Constraints, algebra, jommetry and such ElMaestro 2015-03-31 12:16
- Constraints, algebra, jommetry and such yjlee168 2015-03-31 13:13
- Constraints, algebra, jommetry and such ElMaestro 2015-03-31 14:26
- Constraints, algebra, jommetry and such mittyri 2015-04-01 08:25
- Constraints, algebra, jommetry and such ElMaestro 2015-03-31 14:26
- Proc GLM, lm() do not auto-exclude subjects d_labes 2015-04-01 09:15
- Proc GLM, lm() do not auto-exclude subjects ElMaestro 2015-04-01 16:29
- Constraints, algebra, jommetry and such yjlee168 2015-03-31 13:13
- Constraints, algebra, jommetry and such ElMaestro 2015-03-31 12:16
- to exclude or not to exclude - let the user decide yjlee168 2015-03-31 11:15
- to exclude or not to exclude - let the user decide ElMaestro 2015-03-30 15:44
- to exclude or not to exclude - let the user decide yjlee168 2015-03-30 11:28
- to exclude or not to exclude - let the user decide mittyri 2015-03-29 19:04
- to exclude or not to exclude the subjects with bear? yjlee168 2015-03-28 21:03
- Bear and null PK parameters mittyri 2015-03-25 09:50
- NCA with bear? yjlee168 2015-03-09 15:24
- Subjects to be considered in partial replicate BE study Astea 2015-03-09 14:43
- Subjects to be considered in partial replicate BE study yjlee168 2015-03-01 19:01
- Subjects to be considered in partial replicate BE study Astea 2015-03-01 18:12
- Subjects to be considered in partial replicate BE study d_labes 2015-01-08 09:04
- Subjects to be considered in partial replicate BE study d_labes 2015-01-07 14:45