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Abstract
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| NOTATIONS AND ABBREVIATIONS | ||
| = | The following notations and abbreviations are used in this article. The response variable is a logarithmically transformed BE metric (logAUC or logCmax). | |
| α: | = | Probability |
| AUC: | = | Area under the curve contrasting plasma concentration and time |
| Cmax: | = | Maximum plasma concentration |
| CL: | = | Confidence limit calculated for scaled average bioequiva lence, Eq. (13) |
| CV: | = | Coefficient of variation |
| μT and μR: | = | Means of the test and reference formulations |
| mT and mR: | = | Estimated means of the test and reference formulations |
| N: | = | Number of volunteers |
| S: | = | Number of study sequences |
| SE: | = | Standard error |
| σ0: | = | Switching variation, defines variabilities of HV drugs; σ0 = 0.294 is suggested |
| σ2: | = | Variance; also used as the denominator in Eq.(3) for individual BE |
| σBT2 and σBR2: | = | Between-subject variances of the test and reference formulations |
| σD2: | = | Variance component for subject-by-formulation interaction |
| σRes2: | = | Residual variance in 2-period BE studies; it contains the within-subject variance |
| sRes2: | = | Estimated residual variance in 2-period BE studies; it is calculated as residual variance term in an analysis of variance |
| σW2: | = | Variance related to the within-subject variance; also used as the denominator in Eq.(5) for scaled average BE |
| sW2: | = | Estimated variance related to the within-subject variance |
| σWT2 and σWR2: | = | Within-subject variances of the test and reference formulations |
| sWT2and sWR2: | = | Estimated within-subject variances of the test and reference formulations |
| θA: | = | Regulatory BE limit for average BE, usually log (1.25) |
| θS: | = | Regulatory BE limit for scaled average BE; 0.760 is the suggested value |
Notes
This article has been modified from its original format to conform with the journal style. “Evaluation of bioequivalence of highly variable drugs” was originally printed in Kanfer I, Shargel L. Eds. Generic Drug Product Development: Bioequivalence Issues; 2007: 97–121.
5 American Association of Pharmaceutical Sciences, Symposium on “Bioequivalence of Highly Variable Drugs and Drug Products.” Nashville, TN; Nov 9, 2005.