Comments on "Statistical methodology for highly variable compounds: A novel design approach for the ofatumumab phase 2 bioequivalence study".

Abstract

Pharmaceutical StatisticsEarly View LETTER TO THE EDITOR Comments on “Statistical methodology for highly variable compounds: A novel design approach for the Ofatumumab phase 2 bioequivalence study” Wanjie Sun, Corresponding Author Wanjie Sun wanjie.sun@fda.hhs.gov orcid.org/0000-0002-6919-1939 Division of Biometrics VIII, FDA/CDER/OTS/Office of Biostatistics, Silver Spring, Maryland, USA Correspondence Wanjie Sun, Division of Biometrics VIII, FDA/CDER/OTS/Office of Biostatistics, Silver Spring, MD, USA. Email: wanjie.sun@fda.hhs.govSearch for more papers by this authorDonald J. Schuirmann, Donald J. Schuirmann Division of Biometrics VIII, FDA/CDER/OTS/Office of Biostatistics, Silver Spring, Maryland, USASearch for more papers by this authorStella Grosser, Stella Grosser Division of Biometrics VIII, FDA/CDER/OTS/Office of Biostatistics, Silver Spring, Maryland, USASearch for more papers by this author Wanjie Sun, Corresponding Author Wanjie Sun wanjie.sun@fda.hhs.gov orcid.org/0000-0002-6919-1939 Division of Biometrics VIII, FDA/CDER/OTS/Office of Biostatistics, Silver Spring, Maryland, USA Correspondence Wanjie Sun, Division of Biometrics VIII, FDA/CDER/OTS/Office of Biostatistics, Silver Spring, MD, USA. Email: wanjie.sun@fda.hhs.govSearch for more papers by this authorDonald J. Schuirmann, Donald J. Schuirmann Division of Biometrics VIII, FDA/CDER/OTS/Office of Biostatistics, Silver Spring, Maryland, USASearch for more papers by this authorStella Grosser, Stella Grosser Division of Biometrics VIII, FDA/CDER/OTS/Office of Biostatistics, Silver Spring, Maryland, USASearch for more papers by this author First published: 20 July 2022 https://doi.org/10.1002/pst.2255Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Early ViewOnline Version of Record before inclusion in an issue RelatedInformation