Bioequivalence and Bioavailability Forum

ICH M13A: Changes to Step 2 [BE/BA News]

posted by BEQool  – 2024-09-09 07:48 (264 d 23:55 ago) – Posting: # 24191
Views: 5,252

Hello all,

❝   – Final (page 12)

❝     Randomised, non-replicate, crossover design studies should be analysed using an appropriate parametric method, e.g., general linear model (GLM) or mixed model.

❝     […] The mixed model likely was a concession made to the FDA and Health Canada, the only agencies currently requiring it.

So we can either put subject as a fixed or random effect?

But then the following text comes up:
"The primary statistical analyses should include all data for all subjects who provide evaluable data for both the test and comparator products."

And also in Q&A document:
In a 2-way crossover design, if data from one period are excluded, the subject should not be included in the statistical analysis […]

I am confused, if I understand well, we should all treat subject as a fixed effect?

Regards
BEQool

Complete thread:

• ICH M13A: Changes to Step 2 Helmut 2024-07-31 13:16 
  • ICH M13A: Changes to Step 2 Helmut 2024-07-31 14:19
    • AUCres mittyri 2024-08-05 21:08
      • ‘Percentage covered’ Helmut 2024-08-05 22:13
    • ICH M13A: Changes to Step 2BEQool 2024-09-09 05:48
      • fixed or mixed effects model Helmut 2024-09-09 07:04
        • fixed or mixed effects model BEQool 2024-09-09 10:18
          • fixed or mixed effects model Helmut 2024-09-09 11:13
            • fixed or mixed effects model BEQool 2024-09-10 07:35
        • fixed or mixed effects model Helmut 2024-09-10 08:12
  • ICH M13A: Changes to Step 2 Helmut 2024-08-05 12:53
  • period within group and formulation mittyri 2024-08-05 20:42
    • period within group and formulation Helmut 2024-08-05 22:29
  • ICH M13A: Step 4 → 5 Helmut 2024-08-08 11:57
    • Formal ICH Procedure Helmut 2024-08-09 09:45
  • ICH M13A: Changes to Step 2 Helmut 2024-09-06 08:04