Bioequivalence and Bioavailability Forum • 3-way replicate vs. 4-way

3-way replicate vs. 4-way [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2009-08-20 04:14 (6144 d 16:34 ago) – Posting: # 4070
Views: 10,600

Dear Muneesh!

❝ We are planning 4-period replicate design to reduce the number of subjects

❝ also. Highly variable drug like risedronate having intrasubject variability

❝ of 50-80% would require too many subjects in case of 3-period design. 3-

❝ period design may be ok for drugs having intrasubject variability of 30-50%.

I don't see a difference (when it comes to the number of administered treatments) between CV 30-50% and 50-80%. What is more ethical: to administer N subjects four times or 1½N subjects three times? I just wanted to point out the higher chance of drop-outs, especially taking your long washout into account. On the other hand you may run into problems with the capacity of the clinical site (more groups, logistics).

❝ Please suggest if I am wrong.

There's not right or wrong. Just different points of view.

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

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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-wayHelmut 2009-08-20 02:14
        
        3-way replicate vs. 4-way drmuneesh 2009-08-20 09:28
        
        Ethics: no. of administrations Helmut 2009-08-20 14:05
        
        Ethics: no. of administrations drmuneesh 2009-08-21 10:43