Effects of between-batch variability on the type I error rate in biosimilar development

DOI10.1080/03610918.2019.1650182OpenAlexW2967865342MaRDI QIDQ5086359

Junhui Park, Seung-Ho Kang

Publication date: 5 July 2022

Published in: Communications in Statistics - Simulation and Computation (Search for Journal in Brave)

Full work available at URL: https://doi.org/10.1080/03610918.2019.1650182

zbMATH Keywords

random effect modelequivalence testbeta-binomial modelfollow-on biologic

Mathematics Subject Classification ID

Statistics (62-XX)

Cites Work

• The determination of biosimilarity margin and the assessment of biosimilarity for an (m+1)-arm parallel design

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