Bioequivalence data analysis for the case of separate hospitalization.

作者信息

Bae Kyun-Seop, Kang Seung-Ho

机构信息

Department of Clinical Pharmacology and Therapeutics Asan Medical Center, University of Ulsan, Seoul 05505, Republic of Korea.

Department of Applied Statistics, Yonsei University, Seoul 03722, Republic of Korea.

出版信息

Transl Clin Pharmacol. 2017 Jun;25(2):93-100. doi: 10.12793/tcp.2017.25.2.93. Epub 2017 Jun 15.

DOI:10.12793/tcp.2017.25.2.93

PMID:32133325

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7042005/

Abstract

A bioequivalence study is usually conducted with the same-day drug administration. However, hospitalization is occasionally separated for logistical, operational, or other reasons. Recently, there was a case of separate hospitalization because of difficulties in subject recruitment. This article suggests a better way of bioequivalence data analysis for the case of separate hospitalization. The key features are (1) considering the hospitalization date as a random effect than a fixed effect and 2) using "PROC MIXED" instead of "PROC GLM" to include incomplete subject data.

摘要