Bioequivalence and Bioavailability Forum • Randomisation & Sample Size

Randomisation & Sample Size – Clinical BA Study [Power / Sample Size]

posted by ElMaestro – Denmark, 2011-02-01 15:24 (5625 d 16:43 ago) – Posting: # 6528
Views: 8,253

Hi again,

❝ We are hoping to show that the nutritional supplement increases the

❝ absorption and thus bioavailability of the drug.

❝ (...)

❝ We are also interested in examining if the different doses of the

❝ supplement affect the bioavailability of the drug to a different extent

If you have 'enough' subjects in your pivotal trial you may end up with a significant value for the ingredient addition.
However, in order to dimension such a thing you will need to have an idea about the effect size the dietary supplement. In the absence of a model for it I guess you need to either conduct a pilot trial to get an idea about the effect size in your pivotal trial or press the 'I feel lucky'-button.

—
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 StudyElMaestro 2011-02-01 14:24
      - Randomisation & Sample Size – Clinical BA Study Mike_270 2011-02-02 00:47
        
        Randomisation ElMaestro 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