BElikelihood

Likelihood Method for Evaluating Bioequivalence

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A likelihood method is implemented to present evidence for evaluating bioequivalence (BE). The functions use bioequivalence data [area under the blood concentration-time curve (AUC) and peak concentration (Cmax)] from various crossover designs commonly used in BE studies including a fully replicated, a partially replicated design, and a conventional 2x2 crossover design. They will calculate the profile likelihoods for the mean difference, total standard deviation ratio, and within subject standard deviation ratio for a test and a reference drug. A plot of a standardized profile likelihood can be generated along with the maximum likelihood estimate and likelihood intervals, which present evidence for bioequivalence. See Liping Du and Leena Choi (2015) .


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