highly 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??
Unfortunately, we come back again to this point. Although the GCC GL is adopted from the EMA GL,
but the upper cap of scaling is about only 39% and not 50%!!!!
At the moment, I think you could have a good chance under the conditions that your BE study is demonstrated in a replicate design and that the high within-subject variability for Cmax not caused by outliers.