Bioequivalence and Bioavailability Forum • Remember "Do not's"

Remember "Do not's" [Power / Sample Size]

posted by Nirav Jani – 2011-02-04 20:15 (5613 d 14:10 ago) – Posting: # 6560
Views: 5,913

Dear ElMaestro and d_labes,

Thanks a lot for your reply.

Here we are using pilot data of partial reference replicated (2-treatment, 3 period) crossover design for estimating sample size of pivotal study for same design and this is first time for me to face the situation and I don't know the method to calculate the sample size for 2 treatment, 3 period partial replicated design using the same design.

If we use maximum intra-subject CV of Reference for Cmax (28%) and (T/R) ratio 115%, and calculate sample size as per ABE approach. Now, can we multiply the estimated number by 0.75 for 3 period partial replicated design? Can we go for this approach?

Or

we should not consider the (T/R) ratio for sample size for the pivotal study and should enroll 24 to 36 subjects for pivotal study for ISCV o 28%.

Looking for your valuable suggestions.

Thanks and regards,
Nirav

Complete thread:

Sample size for Pivotal Partial Replicate desing Nirav Jani 2011-02-03 19:32
- Sample size for Pivotal Partial Replicate desing ElMaestro 2011-02-03 20:41
  - Sample size for scaled ABE? d_labes 2011-02-04 12:00
    - Sample size for scaled ABE? ElMaestro 2011-02-04 13:23
      - Remember "Do not's" d_labes 2011-02-04 14:00
        
        Remember "Do not's"Nirav Jani 2011-02-04 19:15