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Biomarkers for progressive multifocal leukoencephalopathy: emerging data for use of JC virus DNA copy number in clinical trials

  • Published:2024-05 Issue:5 Volume:23 Page:534-544
  • ISSN:1474-4422
  • Container-title:The Lancet Neurology
  • language:en
  • Short-container-title:The Lancet Neurology

Author:

Cortese Irene,Norato Gina,Harrington Patrick R,Usher Therri,Mainardi Ilaria,Martin-Blondel Guillaume,Cinque Paola,Major Eugene O,Sheikh Virginia

Funder

National Institute of Neurological Disorders and Stroke

National Institutes of Health

U.S. Food and Drug Administration

Publisher

Elsevier BV

Reference63 articles.

1. Biomarker qualification: toward a multiple stakeholder framework for biomarker development, regulatory acceptance, and utilization;Amur;Clin Pharmacol Ther,2015

2. US Food and Drug Administration. Expedited programs for serious conditions—drugs and biologics. Guidance for industry (accessed March 14, 2024).

3. The neuroradiology of progressive multifocal leukoencephalopathy: a clinical trial perspective;Baldassari;Brain,2022

4. Neurofilaments as biomarkers in neurological disorders;Khalil;Nat Rev Neurol,2018

5. Serum neurofilament levels and PML risk in patients with multiple sclerosis treated with natalizumab;Fissolo;Neurol Neuroimmunol Neuroinflamm,2021

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