Koti Kallappa M
United States Food and Drug Administration, Silver Spring, MD 20993, USA.
J Biopharm Stat. 2007;17(2):229-45. doi: 10.1080/10543400601177426.
Testing for noninferiority and equivalence between an experimental therapy and a standard therapy in terms of the ratio of binomial proportions is considered. New tests based on the Fieller-Hinkley distribution of the ratio of random variables are proposed. Restricted maximum likelihood estimates of the null variances are used to derive the tests. Sample size determination is discussed. The proposed test procedure is extended to multiple tables. The tests are applied to numerical examples.
考虑在二项比例之比方面对实验疗法和标准疗法之间的非劣效性和等效性进行检验。提出了基于随机变量之比的菲勒 - 欣克利分布的新检验方法。使用零方差的受限最大似然估计来推导检验。讨论了样本量的确定。所提出的检验程序扩展到多个表格。将这些检验应用于数值示例。