Clinical cross-over trials in phase I

被引：13
作者：
Senn, S
Ezzet, F
机构：
[1] UCL, Dept Epidemiol & Publ Hlth, London WC1E 6BT, England
[2] Novartis Pharmaceut, Basel, Switzerland
来源：
STATISTICAL METHODS IN MEDICAL RESEARCH | 1999年 / 8卷 / 03期
关键词：
D O I：
10.1191/096228099676112958
中图分类号：
R19 [保健组织与事业（卫生事业管理）];
学科分类号：
摘要：
We review the role of cross-over trials in pharmacokinetic and pharmacodynamic studies, in particular as applied in phase I. Design and analysis considerations are covered. We also consider the use of pharmacokinetic and pharmacodynamic theories in planning cross-over trials. Finally some practical considerations are covered.
引用
收藏
页码：263 / 278
页数：16
相关论文
共 35 条
[1]   CONSIDERATION OF INDIVIDUAL BIOEQUIVALENCE [J].
ANDERSON, S ;
HAUCK, WW .
JOURNAL OF PHARMACOKINETICS AND BIOPHARMACEUTICS, 1990, 18 (03) :259-273
[2]  
Atkinson A.C., 1992, OPTIMUM EXPT DESIGNS
[3]  
Boon P C, 1999, J Biopharm Stat, V9, P109, DOI 10.1081/BIP-100101003
[4]   DIAGNOSTICS FOR HETEROSCEDASTICITY IN REGRESSION [J].
COOK, RD ;
WEISBERG, S .
BIOMETRIKA, 1983, 70 (01) :1-10
[5]  
Davidian M., 1995, NONLINEAR MODELS REP
[6]   Optimum allocation of treatments for Welch's test in equivalence assessment [J].
Dette, H ;
Munk, A .
BIOMETRICS, 1997, 53 (03) :1143-1150
[7]  
Donev A N, 1998, J Biopharm Stat, V8, P249, DOI 10.1080/10543409808835237
[8]  
Fedorov VV., 1972, THEORY OPTIMAL EXPT
[9]  
FLEISS JL, 1989, CONTROLLED CLIN TRIA, V10, P1121
[10]   THE PERFORMANCE OF THE 2-STAGE ANALYSIS OF 2-TREATMENT, 2-PERIOD CROSSOVER TRIALS [J].
FREEMAN, PR .
STATISTICS IN MEDICINE, 1989, 8 (12) :1421-1432
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