Bioequivalence and Bioavailability Forum • Ethics: no. of administrations

Ethics: no. of administrations [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2009-08-20 16:05 (6148 d 00:56 ago) – Posting: # 4078
Views: 10,549

Dear Muneesh!

❝ But I don't really know what is more ethical: to administer N subjects

❝ four times or 1½N subjects three times? I always thought that exposing

❝ less number of subjects to IP is more ethical.

I don't know either. From an ethical point of view, is there a difference in treating two subjects once or one subject twice? For any formulation there's a slight chance of SAEs (hypersentitivity to the API or excipients). From that perspective repeated administrations are definitely better. One the other hand in a four period study blood loss is higher and you are targeting at CV_intra of the test formulation, which is not needed both for scaling (US) or widening of the acceptance range (EU).

Quite interesting discussion!

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

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

Expiry date on medicines drmuneesh 2009-08-10 16:43
- Expiry date on medicines Helmut 2009-08-10 16:52
  - Expiry date on medicines drmuneesh 2009-08-11 07:30
    - 3-way replicate vs. 4-way Helmut 2009-08-11 14:22
      - 3-way replicate vs. 4-way drmuneesh 2009-08-17 05:46
        
        3-way replicate vs. 4-way Helmut 2009-08-20 02:14
        
        3-way replicate vs. 4-way drmuneesh 2009-08-20 09:28
        
        Ethics: no. of administrationsHelmut 2009-08-20 14:05
        
        Ethics: no. of administrations drmuneesh 2009-08-21 10:43