Bioequivalence and Bioavailability Forum

Hi BE-proff,

❝ As far as I know tests to compare results are done at 5% significance level...

Please pay your attention to this problem

❝ About all studies - there are some protocols where lab is assessed only at screening.

Yes, some time ago assessors connived at the protocols where lab tests were performed only during screening (and in case of any AEs during the study)
But now assessors are taking care of this issue, they recommend to specify in protocols that lab tests will be performed at least twice (during the screening and after last sample).

ICH E3 states (and the famous letter from Center of Expertise dated 11.12.13 repeated it):
12.4.2 Evaluation of Each Laboratory Parameter
The necessary evaluation of laboratory values must in part be determined by the results seen, but, in general, the following analyses should be provided. For each analysis, comparison of the treatment and control groups should be carried out, as appropriate, and as compatible with study size. In addition, normal laboratory ranges should be given for each analysis.

BTW I don't know what kind of analysis do the assessors like to see in CSR
Even when I provided just graphs of changes without any analysis of changes I got no LoDs.