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Hello all,
I have a basic question regarding application of Linear Mixed effect model in Bioequivalence
assesment
I have read from literature that for establishing Average Bioequivalence, performing ANOVA on the
AUC, Cmax values and calculating either 90%Confidence Intervals and Hypothesis testing would be
suficient
If its true then what is the necessity of applying LME and calculating the Geometric LSM's etc as we
are not considering any covariates or so
It would be great if any body can brief me on this
Regards
Kaushik
--
K.Harish Kaushik
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Hi Kaushik,
It might be several decades ago to use ANOVA for BE purpose. It cannot be accepted by authorities
anymore I think. LME is the mixture of fixed effect and random effect and ANOVA is only about fixed
effect. So, LME covers ANOVA first. Second, including random effect in BE reflect the thinking on
sampling for the target population. In a BE trial, we are not assessing the BE for those subjects
included in the trial, but the population those subjects are sampled from. Random effect is used
here to describe that subjects are randomly selected from the population.
Hope this helps,
Regards,
Tao Liu BSc
PhD Student
Center for Translational Medicine
University of Maryland, Baltimore
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