Mexico: new guideline [Regulatives / Guidelines]

posted by Ohlbe – France, 2024-07-18 11:40 (359 d 00:38 ago) – Posting: # 24082
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Dear John and Helmut,

❝ Mexico accepts widening the limits in case of high with-subject variability. No details about the statistical method (also about ABE) are given in the guideline of 2013.5 No idea whether a more recent guideline exists.


I found one from January 2023. Refers to RSABE in the text, to the EMA guideline in the bibliography.

Regards
Ohlbe

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