Bioequivalence and Bioavailability Forum • sampleN.RSABE()

sampleN.RSABE() [Power / Sample Size]

posted by AngusMcLean – USA, 2014-06-27 19:37 (3974 d 14:16 ago) – Posting: # 13159
Views: 16,705

Helmut: Thank you for your help and suggestion. It seems that Firefox works for me.

For this work there is no marketed reference formulation; it is a unique MR formulation of an existing drug. We are doing a site change and making pivotal batches and we wish to compare the new site to the original site material, which will be the reference.
Logically we should perform or have performed a Pilot study to get good parameter estimates prior to pivotal. ……”Schadenfreude”

Why I said 0.93 is that I think is a reasonable target for us to aim for a ratio of (0.93-1.07) or perhaps (0.92-1.08). I will use the lower one in future for calculations.

I will try your program; certainly it does look great. There is a mirror near here at N.I.H. in Bethesda,

Angus

Complete thread:

Sample size for replicate design partial AUC AngusMcLean 2014-06-25 02:11 [Power / Sample Size]
- sampleN.RSABE() Helmut 2014-06-25 02:53
  - sampleN.RSABE() AngusMcLean 2014-06-25 13:42
    - sampleN.RSABE() Helmut 2014-06-25 15:02
      - sampleN.RSABE() AngusMcLean 2014-06-25 20:05
        
        sampleN.RSABE() Helmut 2014-06-25 21:29
        
        sampleN.RSABE()AngusMcLean 2014-06-27 17:37
      - power2.TOST() d_labes 2014-06-30 09:47
        
        power2.TOST() Helmut 2014-06-30 12:02
        
        power2.TOST() ElMaestro 2014-06-30 12:31
        
        Elementary, my dear Watson! Helmut 2014-06-30 12:43
        
        Elementary, my dear Watson! ElMaestro 2014-06-30 13:07