An approach for sample size determination of average bioequivalence based on interval estimation
學年 105
學期 2
出版（發表）日期 2017-03-30
作品名稱 An approach for sample size determination of average bioequivalence based on interval estimation
作品名稱（其他語言）
著者 Chieh Chiang; Chin‐Fu Hsiao
單位
出版者
著錄名稱、卷期、頁數 Statistics in medicine 36 (7), 1068-1082
摘要 In 1992, the US Food and Drug Administration declared that two drugs demonstrate average bioequivalence (ABE) if the log-transformed mean difference of pharmacokinetic responses lies in (−0.223, 0.223). The most widely used approach for assessing ABE is the two one-sided tests procedure. More specifically, ABE is concluded when a 100(1 − 2α) % confidence interval for mean difference falls within (−0.223, 0.223). As known, bioequivalent studies are usually conducted by crossover design. However, in the case that the half-life of a drug is long, a parallel design for the bioequivalent study may be preferred. In this study, a two-sided interval estimation — such as Satterthwaite's, Cochran–Cox's, or Howe's approximations — is used for assessing parallel ABE. We show that the asymptotic joint distribution of the lower and upper confidence limits is bivariate normal, and thus the sample size can be calculated based on the asymptotic power so that the confidence interval falls within (−0.223, 0.223). Simulation studies also show that the proposed method achieves sufficient empirical power. A real example is provided to illustrate the proposed method.
關鍵字
語言 en_US
ISSN 1097-0258
期刊性質 國外
收錄於 SCI
產學合作
通訊作者
審稿制度 否
國別 USA
公開徵稿
出版型式 ,電子版
相關連結

機構典藏連結 ( http://tkuir.lib.tku.edu.tw:8080/dspace/handle/987654321/122708 )