Novel Direct Curve Comparison Metrics for Bioequivalence |
| |
Authors: | Polli James E McLean Angus M |
| |
Institution: | (1) School of Pharmacy, University of Maryland, Baltimore, Maryland, 21201;(2) Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, 20 North Pine Street, Baltimore, Maryland, 21201;(3) Shire Laboratories, Rockville, Maryland, 20850 |
| |
Abstract: | Purpose. The object of this work was to devise four new direct curve comparison (DCC) metrics and examine each metric's distribution properties and performance characteristics.
Methods. DCC metrics, Cmax, and AUCi were calculated from two bioequivalence studies of three sustained release carbamazepine formulations, where a range of profile similarity was observed. DCC metric values and their confidence intervals were compared to Cmax and AUCi.
Results. The DCC metrics , m, a, and s exhibited more favorable distributions than Cmax and AUCi ratios, which were frequently skewed. The DCC metrics performed differently than Cmax and AUCi ratios in profile comparisons due to the nature of the DCC metrics. Unlike Cmax and AUCi, the DCC metrics utilize all data points to directly compare entire profiles. Each DCC metric appears to measure exposure in a single assessment. Possible bioequivalence acceptance criteria are: 1.40, m 0.35, a 0.27, and s 0.102.
Conclusions. These DCC metrics, particularly pm, are promising bioequivalence metrics for exposure. |
| |
Keywords: | bioequivalence bioavailability carbamazepine |
本文献已被 PubMed SpringerLink 等数据库收录! |
|