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RegisterNew 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
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
Complete thread:
- New ICH M13a guidance on BE analysisjag009 2025-10-17 21:04 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH M13A (EMA, FDA, HC) Helmut 2025-10-18 12:24
Ing. Helmut Schütz