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Registerclinically relevant Tmax in BE study [Regulatives / Guidelines]
Dear All,
As per ANVISA guideline, for the bioequivalence assessment the parameters Tmax must be considered if clinically relevant. Now what does clinically relevant means? How we can know that this is clinically relevant because generally BE studies are done on healthy subjects??
Hoping for a satisfactory answer.
regards
chak
As per ANVISA guideline, for the bioequivalence assessment the parameters Tmax must be considered if clinically relevant. Now what does clinically relevant means? How we can know that this is clinically relevant because generally BE studies are done on healthy subjects??
Hoping for a satisfactory answer.
regards
chak
Complete thread:
- clinically relevant Tmax in BE studychak 2007-12-26 15:30
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- clinically relevant Tmax in BE study Helmut 2007-12-27 13:43
- clinically relevant Tmax in BE study chak 2007-12-27 15:11
- clinically relevant Tmax in BE study Helmut 2007-12-29 14:38
- clinically relevant Tmax in BE study chak 2007-12-27 15:11
- clinically relevant Tmax in BE study Helmut 2007-12-27 13:43
Ing. Helmut Schütz