Bioequivalence and Bioavailability Forum • New ICH M13a guidance on BE analysis

jag009
★★★

NJ,
2025-10-17 23:04
(248 d 23:45 ago)

Posting: # 24466
Views: 2,263

New ICH M13a guidance on BE analysis [Regulatives / Guidelines]

Hi all,

Does anyone know if the following guideline from ICH M13a (Final, July 2024) has been officially adopted by EMEA, FDA and Health Canada?

"In studies with more than two treatment arms, e.g., a four-period study examining fasting and fed conditions (See Section 2.1.5) or a three-period study including two comparator products or two test products (See Section 2.2.5), the analysis for each comparison should be conducted excluding the data from treatment arms that are not relevant for the comparison in question."

thx
J

Helmut
★★★

Vienna, Austria,
2025-10-18 14:24
(248 d 08:25 ago)

@ jag009
Posting: # 24467
Views: 1,933

ICH M13A (EMA, FDA, HC)

Post reply

Hi John,

❝ Does anyone know if the following guideline from ICH M13a (Final, July 2024) has been officially adopted by EMEA, FDA and Health Canada?

Yes, though the EMEA was rebranded to EMA in 2004. :-D

EMA: Implemented 25 July 2024, effective with 25 January 2025
FDA: October 2024
HC : Will be implemented on 27 December 2025