Zobrazeno 1 - 10
of 10
pro vyhledávání: '"Thomas E. Gwise"'
Autor:
Kelly J. Norsworthy, Xin Gao, Chia-Wen Ko, E. Dianne Pulte, Jiaxi Zhou, Yutao Gong, Yuan Li Shen, Jonathon Vallejo, Thomas E. Gwise, Rajeshwari Sridhara, Albert B. Deisseroth, Ann T. Farrell, R. Angelo de Claro, Gideon M. Blumenthal, Richard Pazdur
Publikováno v:
J Clin Oncol
PURPOSE To explore trial-level and patient-level associations between response (complete remission [CR] and CR + CR with incomplete hematologic [CRi] or platelet [CRp] recovery), event-free survival (EFS), and overall survival (OS) in newly diagnosed
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a53b9bf2442dcabe3676aad1a47631d3
https://pubmed.ncbi.nlm.nih.gov/35007124
https://pubmed.ncbi.nlm.nih.gov/35007124
Autor:
Qi Jiang, Rajeshwari Sridhara, Thomas E. Gwise, Martin Posch, Cindy Lu, Richard Simon, Andrew Raven, Mary W. Redman, Lorenzo Hess, Yuan Li Shen, Kit C.B. Roes, R. Pazdur, Olga Marchenko, Yuan Ji, Scott Berry, Marc R. Theoret, Khadija Rantell
This article summarizes the discussions from the American Statistical Association (ASA) Biopharmaceutical (BIOP) Section Open Forum that took place on December 10, 2020 and was organized by the ASA BIOP Statistical Methods in Oncology Scientific Work
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::25161fc0c4b7915310fa069224e2a3ee
http://arxiv.org/abs/2209.09173
http://arxiv.org/abs/2209.09173
Autor:
Dianne Pulte, Laura Fernandes, Guo Wei, Ashley Woods, Kelly J. Norsworthy, Nicole Gormley, Bindu Kanapuru, Thomas E. Gwise, Richard Pazdur, Julie Schneider, Marc R. Theoret, Lola A. Fashoyin-Aje, R. Angelo de Claro
Publikováno v:
Clinical Lymphoma Myeloma and Leukemia. 23:463-470.e1
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::a360cd1d80774b261fb22417099330c0
https://doi.org/10.1016/j.clml.2023.03.012
https://doi.org/10.1016/j.clml.2023.03.012
Publikováno v:
BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy. 32(4)
To demonstrate a biological product is biosimilar to a reference product, the applicant needs to show that the product is highly similar and has no clinically meaningful differences. Comparative clinical studies are often conducted to support the con
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::92c0d9f210cb7a34114518fe2fffadbd
https://pubmed.ncbi.nlm.nih.gov/30006915
https://pubmed.ncbi.nlm.nih.gov/30006915
Autor:
Thomas E. Gwise
Publikováno v:
Biosimilars ISBN: 9783319996790
The U.S. Food and Drug Administration (FDA) has implemented an abbreviated pathway to market for products that are demonstrated to be biosimilar to or interchangeable with a licensed biological reference product. We discuss comparative clinical studi
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::6266613ba343e7a18fb4188d9369ee3e
https://doi.org/10.1007/978-3-319-99680-6_18
https://doi.org/10.1007/978-3-319-99680-6_18
Autor:
Pulte, Dianne, Fernandes, Laura, Wei, Guo, Woods, Ashley, Norsworthy, Kelly J., Gormley, Nicole, Kanapuru, Bindu, Gwise, Thomas E., Pazdur, Richard, Schneider, Julie, Theoret, Marc R., Fashoyin-Aje, Lola A., de Claro, R. Angelo
Publikováno v:
Clinical Lymphoma, Myeloma & Leukemia; Jun2023, Vol. 23 Issue 6, p463-e1, 9p
Publikováno v:
Medical Letter on the CDC & FDA; 9/17/2023, p1143-1143, 1p
Autor:
National Academies of Sciences, Engineering, and Medicine, Institute of Medicine, Board on the Health of Select Populations, Committee on Shipboard Hazard and Defense II (SHAD II)
Between 1963 and 1969, the U.S. military carried out a series of tests, termed Project SHAD (Shipboard Hazard and Defense), to evaluate the vulnerabilities of U.S. Navy ships to chemical and biological warfare agents. These tests involved use of acti
This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new dru
The second edition of Oncology Clinical Trials has been thoroughly revised and updated and now contains the latest designs and methods of conducting and analyzing cancer clinical trials in the era of precision medicine with biologic agents—includin