jag009
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NJ,
2026-01-20 17:52
(147 d 15:17 ago)

Posting: # 24549
Views: 1,473
 

 AUCinfinity BE requirement for Mexico and Brazil [Regulatives / Guidelines]

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Hi,

Does anyone know if Brazil and Mexico require AUC infinity to be included in the 90% CI BE requirement?

thx
J
 
Helmut
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Vienna, Austria,
2026-01-21 11:55
(146 d 21:14 ago)

@ jag009
Posting: # 24550
Views: 1,200
 

 IR or MR?

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Hi John,

❝ 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 COFEPRIS hasn’t been updated for ages. There are even rumors that BE is not mandatory in Mexico…
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.
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jag009
★★★

NJ,
2026-01-21 19:19
(146 d 13:49 ago)

@ Helmut
Posting: # 24551
Views: 1,169
 

 IR or MR?

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Hi Helmut!

❝ ...There are even rumors that BE is not mandatory in Mexico…

?
J

Edit: As I wrote, rumors. [Helmut]
 
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