Cargando…
Cerebrospinal Fluid Biomarkers for Alzheimer’s Disease: A View of the Regulatory Science Qualification Landscape from the Coalition Against Major Diseases CSF Biomarker Team
Abstract Alzheimer’s disease (AD) drug development is burdened with the current requirement to conduct large, lengthy, and costly trials to overcome uncertainty in patient progression and effect size on treatment outcome measures. There is an urgent need for the discovery, development, and implement...
Autores principales: | Arnerić, Stephen P., Batrla-Utermann, Richard, Beckett, Laurel, Bittner, Tobias, Blennow, Kaj, Carter, Leslie, Dean, Robert, Engelborghs, Sebastiaan, Genius, Just, Gordon, Mark Forrest, Hitchcock, Janice, Kaplow, June, Luthman, Johan, Meibach, Richard, Raunig, David, Romero, Klaus, Samtani, Mahesh N., Savage, Mary, Shaw, Leslie, Stephenson, Diane, Umek, Robert M., Vanderstichele, Hugo, Willis, Brian, Yule, Susan |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
IOS Press
2016
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5115607/ https://www.ncbi.nlm.nih.gov/pubmed/27662307 http://dx.doi.org/10.3233/JAD-160573 |
Ejemplares similares
-
Industry perspectives on biomarker qualification
por: Lavezzari, G, et al.
Publicado: (2015) -
Biomarker Qualification at the European Medicines Agency: A Review of Biomarker Qualification Procedures From 2008 to 2020
por: Bakker, Elisabeth, et al.
Publicado: (2022) -
A user's guide for α‐synuclein biomarker studies in biological fluids: Perianalytical considerations
por: Mollenhauer, Brit, et al.
Publicado: (2017) -
Preanalytical sample handling recommendations for Alzheimer's disease plasma biomarkers
por: Rózga, Małgorzata, et al.
Publicado: (2019) -
Perspectives on statistical strategies for the regulatory biomarker qualification process
por: Hendrix, Suzanne B, et al.
Publicado: (2021)