Bioequivalence and Bioavailability Forum • Replicate Pilot study

Replicate Pilot study [Power / Sample Size]

posted by ElMaestro – Denmark, 2014-04-11 12:27 (4453 d 15:55 ago) – Posting: # 12809
Views: 16,296

Hi Kumarnaidu,

❝ Cmax-62.57(38.27 - 102.29) CV-83.85

❝ AUCt-46.09(17.47 - 121.55) CV-263.48

❝ As per experts study failed drastically because of its design (2x2 cross over), and replicate design should be used here instead of 2x2 design.

❝ In my opinion there may be design issue but the test product is also not upto the mark. Please provide your suggestions. Is there a need of change in design of pilot study or test product modification?

Your estimate of CV's is conditional on the point estimates and thus GMR. If you believe in the CV's you believe in the GMRs. If you don't believe in either then I guess you should have a reason. Technical error during bioanalysis etc etc.
To me, as long as concerns over technical errors etc have not been raised, this just looks like a clear-cut failed development to me. I would not spend as much as $.02 on further studies on the present formulation.

—
Pass or fail!
ElMaestro

Complete thread:

sample size for partial replicate - USFDA niraj.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 studyElMaestro 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