I期临床交叉试验

Clinical cross-over trials in phase I.

作者信息

Senn S, Ezzet F

机构信息

Department of Statistical Science, University College London, UK.

出版信息

Stat Methods Med Res. 1999 Sep;8(3):263-78. doi: 10.1177/096228029900800306.

DOI:10.1177/096228029900800306

PMID:10636338

Abstract

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.

摘要

我们回顾了交叉试验在药代动力学和药效学研究中的作用，特别是在I期试验中的应用。文中涵盖了设计和分析方面的注意事项。我们还考虑了药代动力学和药效学理论在交叉试验设计中的应用。最后介绍了一些实际的注意事项。