Výsledky vyhledávání - "Melissa Veenhuizen"

Interdisciplinary Safety Evaluation for Learning and Decision-Making

Autor: Melissa Veenhuizen, Robert Gordon, Greg Ball, James M. Buchanan, Amy Freedman, Brenda J. Crowe, Barbara A Hendrickson

Publikováno v: Therapeutic Innovation & Regulatory Science. 55:705-716

The FDA IND safety reporting Final Rule (21CFR 312.32) applies to all human drugs and biological products being studied under an Investigational New Drug (IND). A sponsor must file an IND safety report for any serious unexpected suspected adverse rea

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::e49563bfc5aa0d33c09754dfb14bd0cb
https://doi.org/10.1007/s43441-021-00268-x

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Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability

Autor: Jody L. Roth, John K. Towns, Mark H. Mayer, John Michael Beals, Bruce H. Mitlak, Gregory C. Davis, Melissa Veenhuizen, Bruce I. Meiklejohn, Craig Johnson

Publikováno v: Current Medical Research and Opinion. 25:1655-1661

Policy makers around the world are currently considering the creation of a regulatory pathway for follow-on biologics (FOB), which will have to account for the substantial technical challenges associated with FOB development. These challenges will li

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c1e16f6caf4122b3986745fc909df1c9
https://doi.org/10.1185/03007990903017313

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Efficacy and safety of tabalumab, an anti-BAFF monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis and inadequate response to TNF inhibitors: results of a randomised, double-blind, placebo-controlled, phase 3 study

Autor: Bernard Combe, Melissa Veenhuizen, R Ortmann, Thomas Dörner, Pierre-Yves Berclaz, Michael Schiff, Chin Lee, Joel M. Kremer, Anne M. Gill, Thomas Huizinga, Wendy J. Komocsar

Publikováno v: RMD Open
RMD Open : Rheumatic & Musculoskeletal Diseases
RMD Open : Rheumatic & Musculoskeletal Diseases, EULAR ; BMJ, 2015, 1 (1), pp.e000037. ⟨10.1136/rmdopen-2014-000037⟩

Background Tabalumab is a human monoclonal antibody that neutralises B-cell activating factor. Objectives To evaluate tabalumab efficacy and safety in patients with rheumatoid arthritis (RA). Methods This phase 3, randomised, double-blind, placebo-co

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::736681c3d0047e1508d6985467ac37dd
http://europepmc.org/articles/PMC4623366

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Efficacy and Safety of Tabalumab, an Anti-B-Cell-Activating Factor Monoclonal Antibody, in a Heterogeneous Rheumatoid Arthritis Population: Results From a Randomized, Placebo-Controlled, Phase 3 Trial (FLEX-O)

Autor: Paul Emery, Ramesh C. Gupta, Li Xie, Chin Lee, Wendy J. Komocsar, Anne M. Gill, Gregg J. Silverman, Mark C. Genovese, Pierre-Yves Berclaz, Melissa Veenhuizen

Publikováno v: Journal of clinical rheumatology : practical reports on rheumaticmusculoskeletal diseases. 21(5)

Objectives The efficacy and safety of 2 different dosing regimens of tabalumab, a monoclonal antibody that neutralizes membrane-bound and soluble B-cell-activating factor (BAFF), were evaluated in patients with rheumatoid arthritis. Methods In this p

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ff33e7430daea2f3dbc196ffb80ea22c
https://pubmed.ncbi.nlm.nih.gov/26203826

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A 52-week, open-label study evaluating the safety and efficacy of tabalumab, an anti-B-cell–activating factor monoclonal antibody, for rheumatoid arthritis

Autor: Chin Lee, Wendy J. Komocsar, Alastair Kennedy, Pierre-Yves Berclaz, Emery Polasek, Kelly Guerrettaz, Melissa Veenhuizen, Maria Greenwald, Leszek Szczepanski

Publikováno v: Arthritis Research & Therapy

Introduction The objective of this study was to evaluate the long-term safety and efficacy of tabalumab, a monoclonal antibody that neutralizes membrane-bound and soluble B-cell-activating factor, in rheumatoid arthritis (RA) patients. Methods Patien

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5b52bd337b0f4168920e372d8d522ea2
http://europepmc.org/articles/PMC4177512

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A phase 2 dose-ranging study of subcutaneous tabalumab for the treatment of patients with active rheumatoid arthritis and an inadequate response to methotrexate

Autor: Mark C. Genovese, Stephen L. Myers, Olivier Bénichou, Melissa Veenhuizen, Julie Satterwhite, Eric Lee, Gregory D. Sides, Damon Disch, Pierre-Yves Berclaz

Publikováno v: Annals of the rheumatic diseases. 72(9)

To assess the dose-response relationship, efficacy and safety of tabalumab, a human monoclonal antibody that neutralises membrane-bound and soluble B-cell activating factor (BAFF), in patients with rheumatoid arthritis (RA) with inadequate response t

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::341d7517aa9889a20114ac8cf9ffe04b
https://pubmed.ncbi.nlm.nih.gov/23599435

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Tabalumab, an anti-BAFF monoclonal antibody, in patients with active rheumatoid arthritis with an inadequate response to TNF inhibitors

Autor: Stephen L. Myers, Mark C. Genovese, Olivier Bénichou, Roy Fleischmann, Maria Greenwald, Li Xie, Melissa Veenhuizen, Pierre-Yves Berclaz, Julie Satterwhite

Publikováno v: Annals of the rheumatic diseases. 72(9)

Objective To evaluate the efficacy and safety of tabalumab, a monoclonal antibody that neutralises membrane-bound and soluble B-cell activating factor (BAFF), in patients with active rheumatoid arthritis (RA) who showed inadequate response to tumour

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b4a341b150c0467addbd53addf8c0264
https://pubmed.ncbi.nlm.nih.gov/23268367

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OP0184 Efficacy and Safety of Tabalumab in Patients with Systemic Lupus Erythematosus (SLE): Results from 2 Phase 3, 52-Week, Multicenter, Randomized, Placebo-Controlled Trials: Table 1

Autor: M. Silk, Thomas Dörner, M Morgan-Cox, David A. Isenberg, Matthew D. Linnik, Daniel J. Wallace, Joan T. Merrill, Robert W Hoffman, N Iikuni, C. Dickson, Melissa Veenhuizen

Publikováno v: Annals of the Rheumatic Diseases. 74:141.1-141

Background Tabalumab is a human IgG4 monoclonal antibody that binds and neutralizes membrane and soluble BAFF. Objectives Two trials, involving >2000 patients (pts) with SLE, evaluated the efficacy and safety of subcutaneous tabalumab + standard of c

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::eae3d604525a5db88e1885ef2836d706
https://doi.org/10.1136/annrheumdis-2015-eular.1195

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Analysis of reports of human exposure to Micotil 300 (tilmicosin injection)

Autor: Jane G Owens, Robert F McManus, Theressa J Wright, Melissa Veenhuizen

Publikováno v: Journal of the American Veterinary Medical Association. 229(11)

Objective—To identify clinical signs associated with and outcome of human exposure to Micotil 300 (tilmicosin injection). Design—Retrospective case series. Study Population—Reports of 3,168 human exposures to Micotil 300. Procedures—Reports o

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8c6b526506d69e8fd01285f7c36c2215
https://pubmed.ncbi.nlm.nih.gov/17144818

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