Zobrazeno 1 - 10
of 17
pro vyhledávání: '"GREG ANGLIN"'
Autor:
BORIS CALDERON, GARRETT R. MULLINS, MICHAEL HODSDON, GRACE LI, GREG ANGLIN, SHWETA URVA, KAREN SCHNECK, JENNIFER N. BARDOS, RICARDO F. MARTINS, KATELYN BROWN
Publikováno v:
Diabetes. 71
Tirzepatide (TZP) is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon like peptide (GLP) -1 receptor agonist developed for the treatment of type 2 diabetes. Patients receiving TZP may develop an immune response to the 39 amino a
Autor:
Brenda J. Crowe, Seta Shahin, Melvin Munsaka, Mary E. Nilsson, Wei Wang, Greg Ball, Greg Anglin
Publikováno v:
Statistics in Biopharmaceutical Research
article-version (VoR) Version of Record
article-version (VoR) Version of Record
In this paper, we provide guidance on how standard safety analyses and reporting of clinical trial safety data may need to be modified, given the potential impact of the COVID-19 pandemic. The impact could include missed visits, alternative methods f
Autor:
James M. Martinez, Nada Hindiyeh, Sandra Garces, Greg Anglin, William Kielbasa, Kavita Kalidas, Brian A. Moser, Eric M. Pearlman, Michael E Hodsdon
Publikováno v:
Cephalalgia
Background This analysis characterizes the immunogenicity profile of galcanezumab, a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and inhibits its activity, in phase 3 migraine trials. Methods Immunogenicity da
Autor:
Greg Anglin, T. Dwight McKinney, Katherine R. Tuttle, Kristine D. Harper, Jaime A. Davidson, Fady T. Botros
Publikováno v:
Diabetes, Obesity & Metabolism
Dulaglutide is a once-weekly glucagon-like peptide-1 receptor agonist approved for the treatment of type 2 diabetes (T2D). Integrated data from 9 phase II and III trials in people with T2D (N = 6005) were used to evaluate the effects of dulaglutide o
Autor:
Robert J. Konrad, Kenneth F. Mace, Greg Anglin, Wolfgang Glaesner, Zachary Skrivanek, Kristine D. Harper, Zvonko Milicevic, Chrisanthi A. Karanikas
Publikováno v:
Diabetes, Obesity and Metabolism. 18:533-536
Therapeutic administration of peptides may result in anti-drug antibody (ADA) formation, hypersensitivity adverse events (AEs) and reduced efficacy. As a large peptide, the immunogenicity of once-weekly glucagon-like peptide-1 (GLP-1) receptor agonis
Publikováno v:
Therapeutic innovationregulatory science. 50(6)
A recent publication from Eli Lilly and Company provided guidance on incorporation of a structured benefit-risk assessment framework into Section 2.5.6 of the Clinical Overview of marketing authorization applications. Because a template alone cannot
Autor:
Greg Anglin, Sherie A. Dowsett, Brenda J. Crowe, Ann Marie Hake, Roy Yaari, Eric Siemers, Christopher Carlson, Ludmila Kryzhanovskaya, Michael Case, David Perahia, Rashna Khanna, Gopalan Sethuraman
Publikováno v:
Alzheimer's & Dementia. 13
Autor:
Anne M. Wolka, Shelby D. Reed, Michael Siegel, F. Reed Johnson, Greg Anglin, Angelyn O. Fairchild, Rebecca Noel
Publikováno v:
Therapeutic innovationregulatory science. 52(4)
Formal incorporation of patients' perspectives is becoming increasingly important in medical product development and decision making. This article shares practical advice regarding how patient advocacy organizations, the pharmaceutical industry, and
Autor:
Jamie S. Barkin, Greg Anglin, Zvonko Milicevic, Ingrid E. Hensley, Kristine D. Harper, Jean-Louis Frossard, Michael A. Nauck
Publikováno v:
Diabetes care. 40(5)
OBJECTIVE To assess the risk of acute pancreatitis during treatment with glucagon-like peptide 1 receptor agonist dulaglutide, placebo, and active comparators across phase 2/3 dulaglutide trials. RESEARCH DESIGN AND METHODS A total of 6,005 patients
Publikováno v:
The Journal of Clinical Endocrinology & Metabolism. 91:3002-3010
Evidence exists for X-linked parent-of-origin effects in Turner syndrome, because phenotypic and cognitive profiles differ between 45,X(maternal) and 45,X(paternal) individuals.We evaluated the parent-of-origin effect of the intact X chromosome on sp