Bioequivalence and Bioavailability Forum • forget the partial replicate

forget the partial replicate [Power / Sample Size]

posted by Helmut – Vienna, Austria, 2013-10-18 02:14 (4625 d 04:29 ago) – Posting: # 11680
Views: 17,565

Hi Niraj,

❝ 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.

As John suggested go with PowerTOST. I would abandon the lousy partial replicate and opt for a fully replicated 3-period design (TRT|RTR) instead. If by any chance you are not allowed to scale (s_WR <0.294), the partial replicate sometimes fails to converge in any (!) software. If that happens, you are in trouble. You have performed a study and are not able get a result (maybe TYPE=FA0(1) instead of TYPE=FA0(2) works – see this thread).
BTW, for HVDs/HVDPs I would never assume 90% < GMR <111% even if you saw such a GMR in the pilot. The GMR might jump around between studies. Don’t be overly optimistic.

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Complete thread:

sample size for partial replicate - USFDA niraj.bhatt 2013-10-17 08:53
- 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 replicateHelmut 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