Tue 25 Feb, 2014 10:34 pm
I've been trying to understand the statistic approach in calculating Coefficient of Variation (CV) and Power of study in order to answer some questions related to Bioequivalence Study. But i'm totally unable to fully comprehend the whole thing and i hope that you guys here can give me a hand.
Here is the scenario:
We have 1 group of 22 subjects which was divided into 2 groups. Each group will be given TEST product or REFERENCE product and blood samples will be taken. The group will be switched to receive the other treatment after 1 week wash out period, hence yielding 22 readings each for TEST & REF.
For Cmax, Mean TESTcmax = 11.43 ng/ml ; REFcmax = 10.27 ng/ml
Standard deviation Cmax: TESTstdv = 5.88 ; REFstdv= 7.26
The ANOVA table analysis for Cmax:
Source DF ; SS ; MS ; F ; p-value
Total 43 ; 47.6248
Group 1 ; 0.5956 ; 0.5956 ; 0.2677 ; 0.6104
Subjects/groups 20 ; 44.4855 ; 2.2242 ; 18.8076 ; 6.234E-09
Treatments 1 ; 0.0269 ; 0.0269 ; 0.2282 ; 0.6379
Period 1 ; 0.0951 ; 0.0951 ; 0.8046 ; 0.3803
Residual 20 ; 2.3652 ; 0.1182
Calculate the coefficient of variance to support the power of the study.