Methodologic considerations for noninterventional studies of switching from reference biologic to biosimilars.

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作者： Rishi J,Desai ^[1] ; Seoyoung C,Kim ^[1] ; Jeffrey R,Curtis ^[2] ; Jaclyn L F,Bosco ^[3] ; Bernadette,Eichelberger ^[4] ; Charles E,Barr ^[4] ; Catherine M,Lockhart ^[4] ; Brian D,Bradbury ^[5] ; Jerry,Clewell ^[6] ; Hillel P,Cohen ^[7] ; Joshua J,Gagne ^[1] ; Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Switching Workgroup

作者单位： Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts. ^[1] Division of Immunology and Rheumatology, University of Alabama at Birmingham, Birmingham, Alabama. ^[2] Real-World Evidence Solutions, IQVIA™, Cambridge, Massachusetts. ^[3] Biologics and Biosimilars Collective Intelligence Consortium, Alexandria, Virginia. ^[4] Center for Observational Research, Amgen, Inc., Thousand Oaks, California. ^[5] Abbvie, North Chicago, Illinois. ^[6] Sandoz Inc, Princeton, New Jersey. ^[7]

关键词 analytic methods biosimilars pharmacoepidemiology study design switching

主题词指导方针(主题)(Guidelines as Topic);人类(Humans);研究设计(Research Design)

DOI 10.1002/pds.4809

PMID 31298463

发布时间 2021-04-26

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