Bioequivalence and Bioavailability Forum • Mexico: new guideline

Mexico: new guideline [Regulatives / Guidelines]

posted by Ohlbe – France, 2024-07-18 11:40 (145 d 01:28 ago) – Posting: # 24082
Views: 1,659

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

Complete thread:

Brazil, Mexico: Proc GLM or Proc Mixed? jag009 2024-07-17 20:29
- Brazil, Mexico: Proc GLM? Helmut 2024-07-18 09:01
  - Mexico: new guidelineOhlbe 2024-07-18 09:40
    - Mexico: ABEL Helmut 2024-07-18 10:42
      - Mexico: ABEL NK 2024-07-19 07:30
        
        Mexico: ABEL Helmut 2024-07-19 09:26
        
        Mexico: ABEL jag009 2024-07-23 19:43