用于生物等效性的新型直接曲线比较指标。
Novel direct curve comparison metrics for bioequivalence.
作者信息
Polli J E, McLean A M
机构信息
Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore 21201, USA.
出版信息
Pharm Res. 2001 Jun;18(6):734-41. doi: 10.1023/a:1011067908500.
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 rho, rhom, deltaa, and deltas, 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: p < or =1.40, rhom, < or =0.35, deltaa, < or =0.27, and deltas < or =0.102.
CONCLUSIONS
These DCC metrics, particularly rhom, are promising bioequivalence metrics for "exposure."
目的
本研究旨在设计四种新的直接曲线比较（DCC）指标，并考察每个指标的分布特性和性能特征。
方法
从三项缓释卡马西平制剂的两项生物等效性研究中计算DCC指标、Cmax和AUCi，观察到一系列的曲线相似性。将DCC指标值及其置信区间与Cmax和AUCi进行比较。
结果
DCC指标rho、rhom、deltaa和deltas的分布比Cmax和AUCi比值更理想，后者经常呈偏态分布。由于DCC指标的性质，在曲线比较中，DCC指标的表现与Cmax和AUCi比值不同。与Cmax和AUCi不同，DCC指标利用所有数据点直接比较整个曲线。每个DCC指标似乎在单一评估中测量“暴露量”。可能的生物等效性接受标准为：p≤1.40，rhom≤0.35，deltaa≤0.27，deltas≤0.102。
结论
这些DCC指标，尤其是rhom，有望成为衡量“暴露量”的生物等效性指标。
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