教師資料查詢 | 類別: 期刊論文 | 教師: 姜 杰CHIANG, CHIEH (瀏覽個人網頁)

標題: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
語言英文(美國)
ISSN1097-0258
期刊性質國外
收錄於SCI;
產學合作
通訊作者
審稿制度
國別美國
公開徵稿
出版型式,電子版
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