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RegisterAtorvastatin study design [Design Issues]
Hello,
I have some doubts about designing bioequivalence study for atorvastatin ftbl.
First of all, as You all know, according to new EMEA BE guideline, it is not necessary to determine or evaluate metabolites anymore. But we are still afraid that some agencies might ask for metabolites, at least for explanatory purposes. Do we need to measure metabolites in BE study?
And second, if we provide evidence of high variability (during pilot study), is it too complicated to define in Pivotal study Protocol acceptance criteria for Cmax to be widened. What are Your experiences with Drug Agencies about this Cmax widening?
I have some doubts about designing bioequivalence study for atorvastatin ftbl.
First of all, as You all know, according to new EMEA BE guideline, it is not necessary to determine or evaluate metabolites anymore. But we are still afraid that some agencies might ask for metabolites, at least for explanatory purposes. Do we need to measure metabolites in BE study?
And second, if we provide evidence of high variability (during pilot study), is it too complicated to define in Pivotal study Protocol acceptance criteria for Cmax to be widened. What are Your experiences with Drug Agencies about this Cmax widening?
Complete thread:
- Atorvastatin study designbioequa 2011-01-04 11:25
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Atorvastatin study design Helmut 2011-01-04 15:23
- Atorvastatin study design bioequa 2011-01-04 15:44
- Atorvastatin study design Helmut 2011-01-04 17:54
- Atorvastatin study design bioequa 2011-01-04 15:44
- Atorvastatin study design Helmut 2011-01-04 15:23
Ing. Helmut Schütz