Bioequivalence and Bioavailability Forum

Hi Mittyri & BE-proff,

❝ 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.

Should be. A comparison given the sample sizes in BE? Forget it. See again the Q&A(R1) to ICH E3 (remember this post?). It’s up to you to adapt the report according to the study’s needs.

❝ BTW I don't know what kind of analysis do the assessors like to see in CSR

May I ask: What’s the ominous “letter from Center of Expertise”?

❝ Even when I provided just graphs of changes without any analysis of changes I got no LoDs.

I always provide only the original pre- and post-study exams and summary statistics. No comparisons, no bloody shift tables, no graphs, nada.