Statistical considerations in bioequivalence of two area under the concentration–time curves obtained from serial sampling data

Autor:	D. L. Hawkins, Steven Y. Hua, Jihao Zhou
Rok vydání:	2013
Předmět:	Statistics and Probability Logarithm Sample size determination Statistics Degrees of freedom (statistics) Inference Decision rule Statistics Probability and Uncertainty Bioequivalence Type I and type II errors Mathematics Statistical hypothesis testing
Zdroj:	Journal of Applied Statistics. 40:1140-1154
ISSN:	1360-0532 0266-4763
DOI:	10.1080/02664763.2013.780234
Popis:	In this paper, we study the bioequivalence (BE) inference problem motivated by pharmacokinetic data that were collected using the serial sampling technique. In serial sampling designs, subjects are independently assigned to one of the two drugs; each subject can be sampled only once, and data are collected at K distinct timepoints from multiple subjects. We consider design and hypothesis testing for the parameter of interest: the area under the concentration–time curve (AUC). Decision rules in demonstrating BE were established using an equivalence test for either the ratio or logarithmic difference of two AUCs. The proposed t-test can deal with cases where two AUCs have unequal variances. To control for the type I error rate, the involved degrees-of-freedom were adjusted using Satterthwaite's approximation. A power formula was derived to allow the determination of necessary sample sizes. Simulation results show that, when the two AUCs have unequal variances, the type I error rate is better controlled by t...
Databáze:	OpenAIRE
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