Bioequivalence data analysis for the case of separate hospitalization.
10.12793/tcp.2017.25.2.93
- Author:
Kyun Seop BAE
1
;
Seung Ho KANG
Author Information
1. Department of Clinical Pharmacology and Therapeutics Asan Medical Center, University of Ulsan, Seoul 05505, Republic of Korea. ksbae@amc.seoul.kr
- Publication Type:Original Article
- Keywords:
Bioequivalence;
Separate hospitalization;
Mixed effects model
- MeSH:
Hospitalization*;
Statistics as Topic*;
Therapeutic Equivalency*
- From:Translational and Clinical Pharmacology
2017;25(2):93-100
- CountryRepublic of Korea
- Language:English
-
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.
