GCC: HV Cmax (fixed limits) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2020-11-19 11:05 (98 d 01:56 ago) – Posting: # 22068
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Hi nuka2020,

» 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%.
» … the results of Cmax is: 70.46%-141.90%
» Need suggestion whether this studies can be acceptable as per GCC guidelines??

What do you think?
Though you have practically a perfect PE (99.99%) you failed to show BE by far. For the GCC your study was just underpowered.

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Helmut Schütz

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