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Register“Before bioanalysis” – exclusion of subjects [Regulatives / Guidelines]
Dear Dirk, dear All,
I have always considered the sentence "…the decision to exclude a subject from the statistical analysis must be made before bioanalysis." at least as a curiosity (not to say something in-polite).
How could we do that for such allowed reasons (EMA guidance, page 14) following the above sentence nearly direct in the text:
"1) A subject with lack of any measurable concentrations or only very low plasma concentrations for reference medicinal product. A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject). The exclusion of data due to this reason will only be accepted in exceptional cases and may question the validity of the trial.
2) Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation (see carry-over effects below)."
Try this without knowledge of any bioanalytical data
.
Ok, they handle that reasons under "exclusion of data", but in consequence it is the exclusion of subjects (as stated also in the text), at least if we talk 2x2 crossover.
I have always considered the sentence "…the decision to exclude a subject from the statistical analysis must be made before bioanalysis." at least as a curiosity (not to say something in-polite).
How could we do that for such allowed reasons (EMA guidance, page 14) following the above sentence nearly direct in the text:
"1) A subject with lack of any measurable concentrations or only very low plasma concentrations for reference medicinal product. A subject is considered to have very low plasma concentrations if its AUC is less than 5% of reference medicinal product geometric mean AUC (which should be calculated without inclusion of data from the outlying subject). The exclusion of data due to this reason will only be accepted in exceptional cases and may question the validity of the trial.
2) Subjects with non-zero baseline concentrations > 5% of Cmax. Such data should be excluded from bioequivalence calculation (see carry-over effects below)."
Try this without knowledge of any bioanalytical data
.Ok, they handle that reasons under "exclusion of data", but in consequence it is the exclusion of subjects (as stated also in the text), at least if we talk 2x2 crossover.
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Regards,
Detlew
Regards,
Detlew
Complete thread:
- “Before bioanalysis” interpretation – exclusion of subjects Dirk 2012-12-03 00:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- “Before bioanalysis” interpretation – exclusion of subjects Dr_Dan 2012-12-03 12:56
- “Before bioanalysis” interpretation – exclusion of subjects Helmut 2012-12-03 13:43
- “Before bioanalysis” interpretation – exclusion of subjects Dr_Dan 2012-12-03 16:39
- “Before bioanalysis” interpretation – exclusion of subjects Dirk 2012-12-04 02:52
- “Before bioanalysis” – exclusion of subjectsd_labes 2012-12-04 08:33
- “Before bioanalysis” – exclusion of subjects lukamar 2012-12-04 10:11
- “Before bioanalysis” – exclusion of subjects Dirk 2012-12-05 14:04
- “Before bioanalysis” – exclusion of subjects lukamar 2012-12-04 10:11
- “Before bioanalysis” – exclusion of subjectsd_labes 2012-12-04 08:33
- “Before bioanalysis” interpretation – exclusion of subjects Dirk 2012-12-04 02:52
- “Before bioanalysis” interpretation – exclusion of subjects Dr_Dan 2012-12-03 16:39
- “Before bioanalysis” interpretation – exclusion of subjects Helmut 2012-12-03 13:43
- “Before bioanalysis” interpretation – exclusion of subjects Dr_Dan 2012-12-03 12:56
Ing. Helmut Schütz