Bioequivalence and Bioavailability Forum • sample size for partial replicate

sample size for partial replicate - USFDA [Power / Sample Size]

posted by niraj.bhatt – India, 2013-10-17 10:53 (4636 d 18:28 ago) – Posting: # 11669
Views: 18,846

Dear All,

We have a data of partial replicate (TRR,RRT,RTR) pilot study and we have within-subject variability of reference formulation.

Now suppose we want to estimate sample size for pivotal partial replicate (TRR,RRT,RTR) study using pilot study results.

Can we use within-subject variability of reference formulation for sample size calculation of pivotal study?

If yes, can we use observed N or should it be multiplied by 0.75 (for 3 period partial replicate study design) or 0.5 (for 4 period fully replicate study design)?

Your suggestion in this regard will be highly appreciated.

Best regards,
Niraj

Complete thread:

sample size for partial replicate - USFDAniraj.bhatt 2013-10-17 08:53 [Power / Sample Size]
- sample size for partial replicate - USFDA jag009 2013-10-17 15:09
  - sample size for partial replicate - USFDA niraj.bhatt 2013-10-18 08:18
    - Table A3 Helmut 2013-10-18 13:51
      - N=24 or N=27 d_labes 2013-10-18 14:34
        
        in praise of 100,000 sim’s Helmut 2013-10-18 15:02
        N=24 or N=27 niraj.bhatt 2013-10-19 06:19
      - Table A3 niraj.bhatt 2013-10-19 06:18
- forget the partial replicate Helmut 2013-10-18 00:14
  - forget the partial replicate niraj.bhatt 2013-10-18 07:57
    - PowerTOST and RSABE d_labes 2013-10-18 11:16
  - Replicate Pilot study kumarnaidu 2014-04-11 07:37
    - Replicate Pilot study ElMaestro 2014-04-11 10:27
      - Replicate Pilot study kumarnaidu 2014-04-11 12:45
        
        Replicate Pilot study ElMaestro 2014-04-11 13:23
        
        Replicate Pilot study kumarnaidu 2014-04-14 06:22