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Registeris open label study acceptable for Canada after implementation of ICH M13A [Regulatives / Guidelines]
is open label study acceptable for Canada after implementation of ICH M13A guidelines.
Outlier tests are acceptable? if so in full replicate design, if any subject found outlier in particular period for Cmax and AUC, is that subject data should be removed from perticulaer period or from all the periods when calculating pharmacokinetic and statistical analysis?
Edit: Please follow the Forum’s Policy. [Helmut]
Outlier tests are acceptable? if so in full replicate design, if any subject found outlier in particular period for Cmax and AUC, is that subject data should be removed from perticulaer period or from all the periods when calculating pharmacokinetic and statistical analysis?
Edit: Please follow the Forum’s Policy. [Helmut]
Complete thread:
- is open label study acceptable for Canada after implementation of ICH M13Abebacrk 2026-02-12 05:14
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- HC: open label studies acc. to ICH M13A Helmut 2026-02-12 09:03
- HC: open label studies acc. to ICH M13A bebacrk 2026-02-12 09:53
- HC: outliers in replicate designs? Helmut 2026-02-13 10:33
- HC: open label studies acc. to ICH M13A bebacrk 2026-02-12 09:53
- HC: open label studies acc. to ICH M13A Helmut 2026-02-12 09:03
Ing. Helmut Schütz