Ghosh Pulak, Khattree Ravindra
Department of Mathematics and Statistics, Oakland University, Rochester, Michigan 48309-4485, USA.
J Biopharm Stat. 2003 Nov;13(4):719-34. doi: 10.1081/BIP-120024205.
In recent years, bioavailability studies for assessment of bioequivalence between two or more drug formulations have become very popular in drug development. However the current practice for the assessment of bioequivalence suffers from certain serious drawbacks. For example, sometimes these tests fail to control the consumer's risk. In this article a new methodology based on the application of Bayes' factor for solving the average bioequivalence problem is proposed. We compare our approach with the existing methods by using real data sets from the Food and Drug Administration (FDA). Results are further explored using simulation studies.
近年来,用于评估两种或多种药物制剂之间生物等效性的生物利用度研究在药物开发中变得非常普遍。然而,目前评估生物等效性的方法存在一些严重缺陷。例如,有时这些测试无法控制消费者风险。本文提出了一种基于贝叶斯因子应用的新方法来解决平均生物等效性问题。我们使用来自美国食品药品监督管理局(FDA)的真实数据集将我们的方法与现有方法进行比较。通过模拟研究进一步探索结果。