Bioequivalence and Bioavailability Forum

Dear ElMag!

❝ Can anyone let me know if ANVISA accepts BE study designs recommended only by FDA or can they accept already approved EMA designs?

According to the 'old' guidances, nothing special for ANVISA with a few exceptions:

• Narrow therapeutic index drugs. FDA no restrictions (90% CI within 80–125%), EMA narrower limits on a case-to-case base (90% CI within 90–111%), ANVISA 95% CI within 80–125%.
  
• According to presentations by members of ANVISA last May in Ljubljana reference-scaling of Highly Variable Drugs / Drug Products (FDA: AUC, C_max; EMA: C_max) is not acceptable.

❝ I've tried to visit their site and your page for guidelines, but all the links were broken. .

Well, have you seen:

Note: ANVISA is redesigning their website starting in mid-August 2010. Most links are broken with no automatic redirects as of 12 September 2010. We are trying to update links as soon as possible.

I don’t speak Portuguese and don’t know anybody who does. ANVISA’s website was a nightmare from the very beginning and has not improved ever since.