Bioequivalence and Bioavailability Forum

Dear Kelen,

Did you have a look at this thread, just a few lines before your message ?

Regards
Ohlbe

Dear Kelen,

please search the forum first (72 hits). A recent post is this one; maybe have a look at this one also...

Dear Kelen,

using my privileges as the forum's administrator I'll give you a second answer for the Brazilian perspective only.

I don't speak Portuguese, but with the aid of -translate Sections 3.1.2/3.1.2.2. (of RE 1170, 19 Apr 2006) read like this:
The following pharmacokinetic parameters must be determined:
[...] the area under the curve of blood concentration versus time, calculated as infinite time to time zero (ASC0-inf), where ASC0-inf = ASC0-t + Ct / k, where Ct is the last concentration of the drug determined experimentally (above the limit of quantification) and k is the elimination constant of the terminal phase. The ASC0-t should be equal to or greater than 80% of ASC0-inf, except in cases where using ASC truncated;

So according to this resolution one has to estimate k_el and calculate AUC_0-inf; only the 80% coverage is lifted from the requirements. OK, it's part of Brazil legislation, but nevertheless it's nonsense!