Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA

被引：0
|
作者：
Penzenstadler, Justin [1 ]
Earp, Justin C. [2 ]
Heickman, Lauren K. Wood K. [1 ]
Pluchino, Kristen [1 ]
机构：
[1] US FDA, Ctr Drug Evaluat & Res, Div Diabet & Lipid Disorders Obesity, Silver Spring, MD 20740 USA
[2] US FDA, Ctr Drug Evaluat & Res, Div Pharmacometr, Silver Spring, MD USA
来源：
DIABETOLOGIA | 2023年 / 66卷 / 03期
关键词：
D O I：
10.1007/s00125-022-05853-9
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
引用
下载
收藏
页码：603 / 604
页数：2
相关论文
共 50 条
  • [1] Utility of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies: a viewpoint from the FDA
    Justin Penzenstadler
    Justin C. Earp
    Lauren K. Wood Heickman
    Kristen Pluchino
    Diabetologia, 2023, 66 : 603 - 604
  • [2] Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies
    Karpen, Stephen R.
    Dunne, Jessica L.
    Frohnert, Brigitte I.
    Marinac, Marjana
    Richard, Claudia
    David, Sarah E.
    O'Doherty, Inish M.
    DIABETOLOGIA, 2023, 66 (03) : 415 - 424
  • [3] Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies
    Stephen R. Karpen
    Jessica L. Dunne
    Brigitte I. Frohnert
    Marjana Marinac
    Claudia Richard
    Sarah E. David
    Inish M. O’Doherty
    Diabetologia, 2023, 66 : 415 - 424
  • [4] Anti-Islet Autoantibodies in Type 1 Diabetes
    Kawasaki, Eiji
    INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES, 2023, 24 (12)
  • [5] Understanding Islet Autoantibodies in Prediction of Type 1 Diabetes
    Jia, Xiaofan
    Yu, Liping
    JOURNAL OF THE ENDOCRINE SOCIETY, 2023, 8 (01)
  • [6] Type 1 diabetes children without islet autoantibodies at the time of clinical diagnosis are more likely to have islet autoantibodies at birth
    Elfving, M.
    Lindberg, B.
    Lynch, K.
    Sundkvist, G.
    Mansson, M.
    Lernmark, A.
    Ivarsson, S. A.
    DIABETOLOGIA, 2006, 49 : 276 - 277
  • [7] Risk of Progression to Clinical Type 1 Diabetes in Older Adolescents Positive for Islet Autoantibodies
    Waugh, Kathleen
    Rasmussen, Cristy Geno
    Dong, Fran
    Gesualdo, Patricia D.
    Frohnert, Brigitte I.
    Rewers, Marian
    DIABETES, 2023, 72
  • [8] Diurnal Variation of Islet Autoantibodies in Established Type 1 Diabetes
    Dimeglio, Linda A.
    Beam, Craig
    Pearson, James A.
    DIABETES, 2024, 73
  • [9] Persistence of islet autoantibodies after diagnosis in type 1 diabetes
    Long, Anna E.
    George, Gifty
    Williams, Claire L.
    DIABETIC MEDICINE, 2021, 38 (12)
  • [10] Biomarkers in Islet Cell Transplantation for Type 1 Diabetes
    Fatimah T. AlRashidi
    Kathleen M. Gillespie
    Current Diabetes Reports, 2018, 18
12345