Výsledky vyhledávání - "Charles E Barr"

Akademický článek

A causal roadmap for generating high-quality real-world evidence

Publikováno v: Journal of Clinical and Translational Science, Vol 7 (2023)

Increasing emphasis on the use of real-world evidence (RWE) to support clinical policy and regulatory decision-making has led to a proliferation of guidance, advice, and frameworks from regulatory agencies, academia, professional societies, and indus

Externí odkaz: https://doaj.org/article/1b066ab2c2c342e3b214a06e4b384ce1

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Noninflammatory Stress-Induced Remodeling of Mandibular Bone: Impact of Age and Pregnancy

Autor: Roshanak Sharafieh, Ulrike Klueh, Gregory Schwarz, Donald L. Kreutzer, Rong Wu, Charles E. Barr

Publikováno v: Journal of Oral and Maxillofacial Surgery. 79:1147-1155

Purpose The impact of noninflammatory stress, such as aging and pregnancy, on human long bone remodeling is well-established, but little is known about the impact of these stressors on oral bones, including the mandibular bone. To begin to fill this

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::3780a111d27541eccafd53008252001e
https://doi.org/10.1016/j.joms.2020.12.003

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Incidence of Serious Infections and Design of Utilization and Safety Studies for Biologic and Biosimilar Surveillance

Autor: James Marshall, Charles E. Barr, Jie Zhang, Jeffrey S. Brown, Cynthia Holmes, Bernadette Eichelberger, Jeffrey R. Curtis, Neil A. Accortt, Kevin Haynes, Cheryl N. McMahill-Walraven, Gayathri Sridhar, Jerry Clewell, Catherine M Lockhart

Publikováno v: Journal of Managed Care & Specialty Pharmacy. 26:417-490

There is a need for postmarketing evidence generation for novel biologics and biosimilars.To assess the feasibility, strengths, and limitations of the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a6405a01bbc81e123c30e875abee2c18
https://doi.org/10.18553/jmcp.2020.26.4.417

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Mapping from the International Classification of Diseases (ICD) 9th to 10th Revision for Research in Biologics and Biosimilars Using Administrative Healthcare Data

Autor: James Marshall, Aaron B. Mendelsohn, Seoyoung C. Kim, Mengdong He, Charles E. Barr, Adrian J. Santiago Ortiz, Jeffrey R. Curtis, Catherine M Lockhart

Publikováno v: Pharmacoepidemiology and Drug Safety. 29:770-777

Purpose The Centers for Medicare and Medicaid Services (CMS) mandated the transition from ICD-9 to ICD-10 codes on October 1, 2015. Postmarketing surveillance of newly marketed drugs, including novel biologics and biosimilars, requires a robust appro

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::48397ef6aaf786d2f3c78c44fa332c0c
https://doi.org/10.1002/pds.4933

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Capture of biologic and biosimilar dispensings in a consortium of U.S.‐based claims databases: Utilization of national drug codes and Healthcare Common Procedure Coding System modifiers in medical claims

Autor: Huifeng Yun, Aaron B. Mendelsohn, Katelyn J. King, Cynthia Holmes, Annemarie Kline, Charles E. Barr, Jie Zhang, Jeffrey S. Brown, Catherine M Lockhart, James Marshall, Kai Yeung, James Kenney, Cara L. McDermott, Kevin Haynes, John Barron

Publikováno v: Pharmacoepidemiology and Drug Safety. 29:778-785

Purpose To assess the capture of biologics (originator and biosimilar) in the Biologics and Biosimilars Collective Intelligence Consortium (BBCIC) Distributed Research Network (DRN), with a focus on medical claim National Drug Code (NDC), a new data

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::78af7ac6e89bc721344a4a44a31fa9ed
https://doi.org/10.1002/pds.4934

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

Autor: Bernadette Eichelberger, Rishi J. Desai, Seoyoung C. Kim, Catherine M Lockhart, Joshua J. Gagne, Brian D. Bradbury, Jerry Clewell, Charles E. Barr, Jaclyn L F Bosco, Jeffrey R. Curtis, Hillel P. Cohen, Biologics

Publikováno v: Pharmacoepidemiology and Drug Safety. 29:757-769

Purpose As more biosimilars become available in the United States, postapproval noninterventional studies describing biosimilar switching and comparing effectiveness and/or safety between switchers and nonswitchers will play a key role in generating

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6b719ad267fc4c248b90bb310643fe63
https://doi.org/10.1002/pds.4809

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Characteristics and temporal trends in patient registries: focus on the life sciences industry, 1981–2012

Autor: Bryan R Luce, Karin Travers, Mary Beattie, Meghan D. Burns, Rachel H. Sallum, CL Pashos, Charles E. Barr

Publikováno v: Pharmacoepidemiology and Drug Safety

Purpose Patient registries are used to monitor safety, examine real-world effectiveness, and may potentially contribute to comparative effectiveness research. To our knowledge, life sciences industry (LSI)-sponsored registries have not been systemati

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b3c3baad991cf63856dfe0852ef7cae
http://europepmc.org/articles/PMC4407929

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