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RegisterBE study assessment [Regulatives / Guidelines]
Hi All,
There is a guideline for BE-studies developed for EAEC which can be implemented somewhen in future.
This gude contains interesting paragraph:
"...AUC(0–t) must overlap at least 80 % of AUC(0–∞). If this rule is not fulfilled subjects should not be excluded from statistical analysis. But if AUC(0–t) doesn't overlap 80 % AUC(0–∞) in more then 20 % of cases you should doubt this study results.
This requirement is not applicable to studies with blood sampling duration equal or over 72 h
So what to do if AUC(0–t) doesn't overlap 80 % AUC(0–∞) following logic above?
Nobody wants to bury studies with money...
There is a guideline for BE-studies developed for EAEC which can be implemented somewhen in future.
This gude contains interesting paragraph:
"...AUC(0–t) must overlap at least 80 % of AUC(0–∞). If this rule is not fulfilled subjects should not be excluded from statistical analysis. But if AUC(0–t) doesn't overlap 80 % AUC(0–∞) in more then 20 % of cases you should doubt this study results.
This requirement is not applicable to studies with blood sampling duration equal or over 72 h
So what to do if AUC(0–t) doesn't overlap 80 % AUC(0–∞) following logic above?
Nobody wants to bury studies with money...
Complete thread:
- BE study assessmentBE-proff 2016-06-22 11:26 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- BE study assessment d_labes 2016-06-22 15:17
- BE study assessment BE-proff 2016-06-22 21:30
- BE study assessment Astea 2016-07-20 22:43
- BE study assessment BE-proff 2016-06-22 21:30
- BE study assessment d_labes 2016-06-22 15:17
Ing. Helmut Schütz