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RegisterExclusion based on Minimum Non Zero Concentrations [Design Issues]
Hello All,
We are planning pivotal biostudy for one of the highly variable molecule (DR Formulation). We have conducted pilot Ref-replicated biostudy, but were suprised with few observations...
1) Inspite of >35 samples we got last point Cmax in 4 subjects in Reference arm:confused
2) After 3-4 zero concentrations in some subjects, we are getting Cmax immediately in next time point. This is similar to first point Cmax.
3) We got just 2 non zero concentrations in 4 subjects and 3 non zero concentrations in 3 subjects in Reference arm. Concentrations are rising and falling very sharply.
:
We are planning to keep an exclusion criteria in our Pivotal study like.
Subjects having minimum of 4 non zero concentrations will be included in the study if first and last points are not Cmax.
Please guide on regulatory acceptability (particularly for USFDA) of such criterion.
If this can be handeled with some other criteria, please suggest...
We are planning pivotal biostudy for one of the highly variable molecule (DR Formulation). We have conducted pilot Ref-replicated biostudy, but were suprised with few observations...
1) Inspite of >35 samples we got last point Cmax in 4 subjects in Reference arm:confused
2) After 3-4 zero concentrations in some subjects, we are getting Cmax immediately in next time point. This is similar to first point Cmax.
3) We got just 2 non zero concentrations in 4 subjects and 3 non zero concentrations in 3 subjects in Reference arm. Concentrations are rising and falling very sharply.
:
We are planning to keep an exclusion criteria in our Pivotal study like.
Subjects having minimum of 4 non zero concentrations will be included in the study if first and last points are not Cmax.
Please guide on regulatory acceptability (particularly for USFDA) of such criterion.
If this can be handeled with some other criteria, please suggest...
Complete thread:
- Exclusion based on Minimum Non Zero Concentrationshiren379 2012-12-11 05:31
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Exclusion based on Minimum Non Zero Concentrations drgunasakaran1 2012-12-11 05:53
- Exclusion based on Minimum Non Zero Concentrations hiren379 2012-12-11 06:03
- Exclusion based on Minimum Non Zero Concentrations drgunasakaran1 2012-12-11 09:02
- Exclusion based on Minimum Non Zero Concentrations hiren379 2012-12-11 06:03
- Exclusion based on Minimum Non Zero Concentrations drgunasakaran1 2012-12-11 05:53
Ing. Helmut Schütz