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Journal of Biopharmaceutical Statistics Volume 34, 2024 - Issue 3
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Research Article

Statistical considerations for some issues in clinical bridging studies evaluating companion diagnostic devices

Changhong SongDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USAView further author information
,
Xiaoqin XiongDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USAView further author information
,
Sunghee KimDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USAView further author information
,
Zhiheng XuDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USAView further author information
,
Dandan XuDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USAView further author information
&
Bipasa BiswasDivision of Biostatistics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland, USACorrespondence[email protected]
View further author information
Pages 441-452 | Received 29 Jul 2022, Accepted 26 May 2023, Published online: 18 Jun 2023

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