CV 0.03%? [Study Per­for­mance]

posted by Helmut Homepage – Vienna, Austria, 2014-06-07 15:52 (3609 d 18:40 ago) – Posting: # 13041
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Hi Khaoula,

❝ […] the drug is omeprazole, that is a HVDP (in bibliography I read a lot of bioequivalence stydy were CV > 30%)


Agree.

❝ […] CV C max of the study Was very low!!!!!!!!


The 0.03% you stated above are practically impossible. Even if you had only monozygotic multiples in your study (violating the “independence” of IID) there would still be variability of the bioanalytical method as a component of the residual variance. Exceptionally good methods still have a CV of ~2–3%. The lowest CVintra of Cmax I ever have seen was ~7% (more than two orders of magnitude higher than yours). Please check your calculations:

\(CV\% = 100\sqrt{e^{MSE}-1}\), where MSE is obtained from ANOVA/GLM of ln-transformed data.

Avoid Kinetica.

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