Bioequivalence and Bioavailability Forum • AUCres

AUCres [BE/BA News]

posted by mittyri – Russia, 2024-08-05 23:08 (128 d 06:54 ago) – Posting: # 24136
Views: 4,153

Dear Helmut,

❝ – Final (page 11)

❝ For single-dose studies, the following PK parameters should be tabulated for each subject-formulation combination: 1) primary parameters for BE analysis: AUC_(0–t), C_max, and, where applicable, early exposure parameters (see Section 2.1.8.3), and 2) additional parameters for analysis to assess the acceptability of the bioequivalence study: AUC_(0–inf), AUC_(0–t)/AUC_(0–inf), t_max, k_el, and t_1/2. For single-dose studies, AUC_(0–t) should cover at least 80% of AUC_(0–inf). If the AUC_(0–t)/AUC_(0–inf) percentage is less than 80% in more than 20% of the observations, then the validity of the study may need to be discussed in the submission.

ICH group was copying many things from EMA BE Guideline (and this is good). But what prompted the ICH group to replace the Residual Area term with Ratio? Was there some kind of dissatisfaction with the 80% coverage criterion and the ambiguity surrounding Residual Area? :-D

I was always wondering about this kind of discussion. One more theme for sensitivity analysis? :cool:

—
Kind regards,
Mittyri

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
  - AUCresmittyri 2024-08-05 21:08
    - ‘Percentage covered’ Helmut 2024-08-05 22:13
  - ICH M13A: Changes to Step 2 BEQool 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