regulatory reasons to consider the study inadequate [Study As­sess­ment]

posted by Astea – Russia, 2019-03-02 17:02 (601 d 22:31 ago) – Posting: # 19987
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Dear Friends!

In the appendix of The Guideline on the Investigation on Bioequivalence (CPMP/EWP/QWP/1401/98 Rev.1) there is a Table 3.2 Additional pharmacokinetic data for <analyte> in <study ID>, where it is supposed to put information about the records where Cmax is the first point (as well as records where AUC0-t/AUC0-∞<0.8 and records where pre-dose sample > 5% Cmax). Could the regulators ban the results of the BE study with such data? Did you ever faced with this in your practice? What was the percentage of subjects with such data (for example for 0.8 it is common to suppose more than 20%)? If there is only one or two subjects with Cmax in the first point should we perform additional analysis excluding them in order to show that this doesn't affect the results if it was not stated in the protocol?

Edit: Appendix IV linked. [Helmut]

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