highly variable drugs-Cmax [Regulatives / Guidelines]

posted by wienui  – Germany/Oman, 2020-11-19 19:04 (743 d 05:19 ago) – Posting: # 22069
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(edited by wienui on 2020-11-20 07:13)

Hi nuka & Helmut,

❝ 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:


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.

Cheers,
Osama

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