Bioequivalence and Bioavailability Forum • EMA: No problems with many sampling time points…

EMA: No problems with many sampling time points… [BE/BA News]

posted by Helmut – Vienna, Austria, 2023-06-28 17:59 (564 d 07:05 ago) – Posting: # 23633
Views: 4,853

Hi Divyen,

❝ ❝ […] Good luck in sampling every five minutes.

❝

❝ But will increase in sampling lead to higher blood loss and then proposal to reduce sampling by IRB/IEC? Or will there be any hope of great BA method so that sampling at every 5/10 min is feasible with minimal blood loss?

Just to quote the overview of comments to the ibuprofen guidance:

Comment: This will lead to credible feasibility and ethical concerns.
Outcome: Every 5 minutes around T_max is enough. Every 15 minutes is the standard frequency, therefore, there is no critical change. No ethical concern is anticipated if the volume of blood is not excessive. The present bioanalytical methods allow to sample less than 300 ml of blood in total in studies with up to 25 samples. Therefore a few more samples for a proper characterisation of T_max and C_max are not considered an ethical problem.

Well roared, lion!

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

EMA: New product-specific guidances Helmut 2022-04-08 15:17 [BE/BA News]
- How would you implement it? ElMaestro 2022-04-09 11:45
  - Confuse a Cat Inc. Helmut 2022-04-09 18:40
    - Confuse a Cat Inc. ElMaestro 2022-04-09 21:47
      - Confuse a Cat Inc. Ohlbe 2022-04-11 11:29
        
        Confuse a Cat Inc. Helmut 2022-04-11 13:59
        
        Range Ohlbe 2022-04-11 15:48
        
        Range Helmut 2022-04-11 16:07
        
        Range Ohlbe 2022-04-11 16:20
        
        Range Helmut 2022-07-28 14:43
      - So many questions, so few answers Helmut 2022-04-11 13:03
      - Preliminary simulations Helmut 2022-04-30 14:59
        
        Preliminary simulations ElMaestro 2022-04-30 19:10
        
        Preliminary simulations Helmut 2022-05-01 15:56
        Revisions of the PSGLs final Helmut 2023-06-23 13:29
        
        Revisions of the PSGLs final dshah 2023-06-28 14:43
        
        EMA: No problems with many sampling time points…Helmut 2023-06-28 15:59
        New simulations & some desultory thoughts Helmut 2023-06-29 11:34
        
        SCNR. A heretic alternative. Helmut 2023-06-30 11:50
      - Simulated distributions Helmut 2022-05-02 13:43