Bioequivalence and Bioavailability Forum

‘Percentage covered’ [BE/BA News]

posted by Helmut  – Vienna, Austria, 2024-08-06 00:13 (69 d 14:13 ago) – Posting: # 24137
Views: 3,123

Hi Mittyri,

❝ 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?

Not the slightest idea. I know a few members of the group and can ask. Answer not guaranteed.

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Edit 1: Perhaps the members were not familiar with what is given in the output of PK software (Phoenix WinNonlin, PKanalix, PKNCA (), ncappc (), NonCompart (), ncar (), Pumas (Julia), …):

AUClast, AUCINF_obs, AUCINF_pred, AUC_%Extrap_obs, AUC_%Extrap_pred or similar

Since the ‘percentage covered’ (\(\small{100\times AUC_{{0-}\text{t}}/AUC_{0-\infty}}\)) is not part of the output, we have to set up any of these transformations (terminology used by the first three goodies above):

• 100 * AUClast / AUCINF_obs
  
• 100 * AUClast / AUCINF_pred
  
• 100 - AUC_%Extrap_obs
  
• 100 - AUC_%Extrap_pred

Until software is updated to automatically provide something like AUC_%Covered_obs and AUC_%Covered_pred we have to live with it.

An example of the setup in Phoe­nix Win­Non­lin (at the bottom the User Defined Parameters and on top the last lines of the Core output):

Output Data Final → Final Parameters Pivoted (last columns)

Table after some transformations and cosmetics:

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Edit 2: I realized that the guideline does not require a breakdown by treatment but »… 20% of the observations …« Therefore:

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна! 
Helmut Schütz


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Complete thread:

• ICH M13A: Changes to Step 2 Helmut 2024-07-31 13:16 [BE/BA News] 
  • 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 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