Bioequivalence and Bioavailability Forum

Linear model and 80–120% [Power / Sample Size]

posted by Anu – India, 2013-10-07 11:59 (4222 d 08:21 ago) – Posting: # 11614
Views: 7,576

Hi Helmut,

Thankyou so much for your esteemed reply.

❝ You need the intrasubject CV from your study (untransformed data). If it is not given in the study report calculate it as CV_intra = √MSE/LSM_R.

Calculated the Intrasubject CV(%) came out 5.83 % (yes its very low).
With the help of Fartssie Sample Size Calculation sheet and R-Software, I find sample size. For this study I have added the values of SD(0.17) & Difference (0.69) in the equivalence crossover and got sample size 5.

Am I right? Is there any other method kindly suggest.

❝               n     T (SD)      R (SD)    80–120% of R   AR* for T–R  90% CI of T–R

❝ linked study  49  16.01±3.40  17.35±3.39  13.88–20.82   –3.47, +3.47  –3.17, –0.80

❝ your study    21  11.54±0.17  12.23±0.17   9.78–14.67   –2.45, +2.45  –1.07, –0.30

Thanx I got it.

Thanks & Regards
Anu

Complete thread:

• Sample Size Anu 2013-09-04 07:03 
  • Sample Size Dr_Dan 2013-09-04 09:52
  • Linear model and Fieller… Helmut 2013-09-04 13:20
    • Linear model and Fieller… jag009 2013-09-04 17:23
      • Linear model and Fieller… Anu 2013-10-04 13:16
        • Linear model and 80–120% Helmut 2013-10-04 15:20
          • Linear model and 80–120%Anu 2013-10-07 09:59
            • CVintra < CVtotal? Helmut 2013-10-07 14:14