Bioequivalence and Bioavailability Forum • Randomisation

Randomisation [Power / Sample Size]

posted by ElMaestro – Denmark, 2011-02-02 09:48 (5614 d 22:52 ago) – Posting: # 6536
Views: 8,237

Hi Mike,

❝ In terms of randomisation, did you have any

❝ comment about using the Williams design 4 treatment sequence design vs. a

❝ single treatment sequence (eg. ABCD)? Is it always better to randomise the

❝ treatment sequences even with small patient numbers?

There are pros and cons.
Of course you get rid of a period effect by randomising and that in itself can be an advantage.
On the other hand, if your drug has en evil safety profile then your dietary supplement may precipitate AEs or SAEs due to increased absorption. In that case it might be a good idea to consistently start low and go high higher.
Specific ADME properties of the drug and effects of the diet supplement on metabolism will also play a role.

Tell some more, please.

—
Pass or fail!
ElMaestro

Complete thread:

Randomisation & Sample Size – Clinical BA Study Mike_270 2011-02-01 11:39
- Randomisation & Sample Size – Clinical BA Study ElMaestro 2011-02-01 12:08
  - Randomisation & Sample Size – Clinical BA Study Mike_270 2011-02-01 13:18
    - Randomisation & Sample Size – Clinical BA Study ElMaestro 2011-02-01 14:24
      - Randomisation & Sample Size – Clinical BA Study Mike_270 2011-02-02 00:47
        
        RandomisationElMaestro 2011-02-02 08:48
- Take all you can get d_labes 2011-02-02 10:36
  - Take all you can get Mike_270 2011-02-02 11:41
    - Budgetary stuff d_labes 2011-02-02 12:13