Good question, next question [Study As­sess­ment]

posted by Helmut Homepage – Vienna, Austria, 2019-03-03 19:42  – Posting: # 19990
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Hi Nasty,

» […] 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?

OK, let’s have a look at the guideline:

Sampling times

Reasons for exclusion

My personal summary:If nothing is stated in the protocol, assessors love a sensitivity analysis. However, if the full data set fails and the one after exclusion passes, don’t hope for too much. Then it depends on the “whole body of evidence”. If this is one study of an entire set, chances for approval are still there. If not, very unlikely.

Cheers,
Helmut Schütz
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