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Registerhighly variable drugs-Cmax [Regulatives / Guidelines]
According to the GCC guidelines a wider range of Cmax(i.e 75-133%) can be acceptable for HVDP, where it has been demonstrated that the within- subject variability for Cmax of the reference compound in the study is >30%.
But, i have a study which was performed as per Eu guidelines and accordingly, the acceptance criteria for Cmax can be widened to a maximum of 69.84 – 143.19%. Accordingly, the results of Cmax is: 70.46%-141.90%
Need suggestion whether this studies can be acceptable as per GCC guidelines??
But, i have a study which was performed as per Eu guidelines and accordingly, the acceptance criteria for Cmax can be widened to a maximum of 69.84 – 143.19%. Accordingly, the results of Cmax is: 70.46%-141.90%
Need suggestion whether this studies can be acceptable as per GCC guidelines??
Complete thread:
- highly variable drugs-Cmaxnuka2020 2020-11-19 11:09
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- GCC: HV Cmax (fixed limits) Helmut 2020-11-19 12:05
- highly variable drugs-Cmax wienui 2020-11-19 18:04
- highly variable drugs-Cmax Helmut 2020-11-19 20:58
Ing. Helmut Schütz