Abstract:
:A new three-arm parallel design was recently proposed to investigate the biosimilarity between a biological product and a reference product by using the relative distance. The purpose of this article is to extend their results to binary endpoints for three popular metrics: the risk difference, the log relative risk, and the log odds ratio. The relative distances based on the three metrics are defined, and corresponding test procedures are developed. The type I error rates and powers are investigated theoretically and empirically.
journal_name
J Biopharm Statjournal_title
Journal of biopharmaceutical statisticsauthors
Shin W,Kang SHdoi
10.1080/10543406.2014.979195subject
Has Abstractpub_date
2016-01-01 00:00:00pages
227-39issue
2eissn
1054-3406issn
1520-5711journal_volume
26pub_type
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