Bioequivalence and Bioavailability Forum

Dear Jaime!

❝ Unfortunately, maybe due to any cultural reason, it is difficult to get a positive return from some of the volunteers in these cases.

I think that this is not due to cultural differences. Subjects rarely ‘confess’ that they have violated study’s restrictions fearing they will never be included again (not without a cause…).

❝ But we are quite sure this was the case, since levels are almost 5% of the Cmax, which is compatible with taking a pill from 3 to 7 days earlier.

Even if you don’t get a positive response from the volunteer I would include this reasoning in the report.

❝ ❝ ... To be honest I have given up to fix the many broken links in the Guidance page. Do you have a working URL?

❝

❝ I'll have a look, hoping to provide you the correct links nowadays.

THX, would be nice. I asked colleagues from ANVISA personally and by e-mail numerous times. They all agreed to help, but actually never did…