Translational and Clinical Pharmacology  2017;25(2):93-100

doi:10.12793/tcp.2017.25.2.93

Bioequivalence data analysis for the case of separate hospitalization.

Kyun Seop BAE 1 ; Seung Ho KANG

Affiliations

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Keywords

Bioequivalence; Separate hospitalization; Mixed effects model

Country

Republic 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.