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RegisterIR or MR? [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2026-01-21 11:55 (145 d 06:35 ago) – Posting: # 24550
Views: 1,194
Hi John,
I guess (‼):
The website of ANVISA is a mess.
As of today ICH M13A for IR of 24 July 2024 is not yet implemented by both agencies.
❝ Does anyone know if Brazil and Mexico require AUC infinity to be included in the 90% CI BE requirement?
I guess (‼):
- IR: AUC0–t or AUC0–72 if t½ > 24 h
- MR: AUC0–t and AUC0–∞; AUC0–72 not acceptable (makes sense)
The website of ANVISA is a mess.
As of today ICH M13A for IR of 24 July 2024 is not yet implemented by both agencies.
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- AUCinfinity BE requirement for Mexico and Brazil jag009 2026-01-20 16:52
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- IR or MR?Helmut 2026-01-21 10:55
- IR or MR? jag009 2026-01-21 18:19
- IR or MR?Helmut 2026-01-21 10:55
Ing. Helmut Schütz