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Registerto exclude or not to exclude - let the user decide [RSABE / ABEL]
Dear Yung-jin,
Yes, you're right, at this moment it is impossible to make a software "push a button" (BTW some subjects tried)
So only pharmacokinetist can make a decision about the data (is it evaluable or not).
I would not delegate the responsibility to the software.
In the meantime I think Bear can report to the user some helpful comments (e.g. "please be informed that only 3 evaluable points are provided for subject# in period#"). So user can make a decision: to exclude this data or not.
As I understood the PK guru's in the mentioned thread:
Helmut wrote:
"I would exclude the subject and maybe the other subjects with only one or two concentrations as well."
ElMaestro answered: "If the software throws an error for the log step without executing a default solution, then I think it is justified to introduce NA's where the software can't logarithmise and then let the chips run their course. Otherwise it is a choice between analysing something or analysing nothing (which is unethical)."
Grey zone of BE...
I would add a row to the options, where the user can decide what to do with this data: to exclude the subject from analysis or to mark the data of period as NA
Anyway my suggestions could be wrong, I'll be glad to see the additional comments from another PK members
❝ What if the subject with only 2-3 evaluable data available as Helmut said in your pointed thread? It may still cause the problem too.
Yes, you're right, at this moment it is impossible to make a software "push a button" (BTW some subjects tried)
So only pharmacokinetist can make a decision about the data (is it evaluable or not).
I would not delegate the responsibility to the software.
In the meantime I think Bear can report to the user some helpful comments (e.g. "please be informed that only 3 evaluable points are provided for subject# in period#"). So user can make a decision: to exclude this data or not.
❝ I don't quite understand here: if you can exclude the subjects who do not have evaluable data point available beforehand, why not?
As I understood the PK guru's in the mentioned thread:
Helmut wrote:
"I would exclude the subject and maybe the other subjects with only one or two concentrations as well."
ElMaestro answered: "If the software throws an error for the log step without executing a default solution, then I think it is justified to introduce NA's where the software can't logarithmise and then let the chips run their course. Otherwise it is a choice between analysing something or analysing nothing (which is unethical)."
Grey zone of BE...
I would add a row to the options, where the user can decide what to do with this data: to exclude the subject from analysis or to mark the data of period as NA
Anyway my suggestions could be wrong, I'll be glad to see the additional comments from another PK members
—
Kind regards,
Mittyri
Kind regards,
Mittyri
Complete thread:
- Statistical Analysis section of partial replicate BE study cher0424 2015-01-07 06:39 [RSABE / ABEL]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 EU mittyri 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 decidemittyri 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 decidemittyri 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
Ing. Helmut Schütz