Schall R
Department of Pharmacology, University of the Orange Free State, Bloemfontein, South Africa.
Biometrics. 1995 Jun;51(2):615-26.
In this paper a new method for the assessment of both individual and population bioequivalence is proposed that is derived from the approach of Schall and Luus (1993, Statistics in Medicine 12, 1109-1124). The method considers the probability that the bioavailability of the test product is close to the bioavailability of the reference product, against the probability that the bioavailability of the reference product is close to itself when administered on different occasions. The method can accommodate unequal variances of the bioavailabilities of the test and reference formulations, as well as formulation by subject interaction. It is thus as general and comprehensive as the methods proposed by Sheiner (1992, Statistics in Medicine 11, 1777-1778) and Schall and Luus (1993), but the resulting bioequivalence criteria are simple and easy to interpret.
本文提出了一种评估个体生物等效性和群体生物等效性的新方法，该方法源自Schall和Luus（1993年，《医学统计学》12卷，1109 - 1124页）的方法。该方法考虑了测试产品的生物利用度接近参比产品生物利用度的概率，与参比产品在不同给药场合下自身生物利用度接近的概率。该方法可以处理测试制剂和参比制剂生物利用度的不等方差，以及制剂与个体间的相互作用。因此，它与Sheiner（1992年，《医学统计学》11卷，1777 - 1778页）以及Schall和Luus（1993年）提出的方法一样通用和全面，但所得出的生物等效性标准简单且易于解释。
