Bioequivalence and Bioavailability Forum

Hello Helmut

❝ Levothyroxine is not considered an NTID in Canada. No product specific GL in the US, but Liothyronine is also not considered an NTID.

In fact, there is a US guideline (Levothyroxine), but it is very controversial, with a number of critical papers written about same in the last 10 years.

❝ In Europe NTIDs are assessed on a case-by-case basis. Little is published yet (tacrolimus: AUC 90%-111%, C_max 80%-125%; ciclosporine: AUC and C_max 90%-111%).

❝ Would be interesting to know how Denmark will defend their requirements (updated on 8 Feb 2010) in the light of European harmonization (all immunosuppressives AUC and C_max 90%-111% vs. EMA-Q&A tacrolimus AUC 90%-111%, C_max 80%-125%).

Fair comment. I'll tell my client to seek regulatory advice before proceeding.

Kind regards

Andrew