highly variable drugs-Cmax [Regulatives / Guidelines]

posted by nuka2020 – United Arab Emirates, 2020-11-19 11:09 (381 d 14:15 ago) – Posting: # 22067
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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?? :confused::confused:

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