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Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities

Biological treatment development for syndromal neuropsychiatric conditions such as autism has seen slow progress for decades. Speeding drug discovery may result from the judicious development and application of biomarker measures of brain function to select patients for clinical trials, to confirm t...

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Detalles Bibliográficos
Autores principales: Ewen, Joshua B., Sweeney, John A., Potter, William Z.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6712089/
https://www.ncbi.nlm.nih.gov/pubmed/31496945
http://dx.doi.org/10.3389/fnint.2019.00045
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author Ewen, Joshua B.
Sweeney, John A.
Potter, William Z.
author_facet Ewen, Joshua B.
Sweeney, John A.
Potter, William Z.
author_sort Ewen, Joshua B.
collection PubMed
description Biological treatment development for syndromal neuropsychiatric conditions such as autism has seen slow progress for decades. Speeding drug discovery may result from the judicious development and application of biomarker measures of brain function to select patients for clinical trials, to confirm target engagement and to optimize drug dose. For neurodevelopmental disorders, electrophysiology (EEG) offers considerable promise because of its ability to monitor brain activity with high temporal resolution and its more ready application for pediatric populations relative to MRI. Here, we discuss conceptual/definitional issues related to biomarker development, discuss practical implementation issues, and suggest preliminary guidelines for validating EEG approaches as biomarkers with a context of use in neurodevelopmental disorder drug development.
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spelling pubmed-67120892019-09-06 Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities Ewen, Joshua B. Sweeney, John A. Potter, William Z. Front Integr Neurosci Neuroscience Biological treatment development for syndromal neuropsychiatric conditions such as autism has seen slow progress for decades. Speeding drug discovery may result from the judicious development and application of biomarker measures of brain function to select patients for clinical trials, to confirm target engagement and to optimize drug dose. For neurodevelopmental disorders, electrophysiology (EEG) offers considerable promise because of its ability to monitor brain activity with high temporal resolution and its more ready application for pediatric populations relative to MRI. Here, we discuss conceptual/definitional issues related to biomarker development, discuss practical implementation issues, and suggest preliminary guidelines for validating EEG approaches as biomarkers with a context of use in neurodevelopmental disorder drug development. Frontiers Media S.A. 2019-08-21 /pmc/articles/PMC6712089/ /pubmed/31496945 http://dx.doi.org/10.3389/fnint.2019.00045 Text en Copyright © 2019 Ewen, Sweeney and Potter. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Neuroscience
Ewen, Joshua B.
Sweeney, John A.
Potter, William Z.
Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities
title Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities
title_full Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities
title_fullStr Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities
title_full_unstemmed Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities
title_short Conceptual, Regulatory and Strategic Imperatives in the Early Days of EEG-Based Biomarker Validation for Neurodevelopmental Disabilities
title_sort conceptual, regulatory and strategic imperatives in the early days of eeg-based biomarker validation for neurodevelopmental disabilities
topic Neuroscience
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6712089/
https://www.ncbi.nlm.nih.gov/pubmed/31496945
http://dx.doi.org/10.3389/fnint.2019.00045
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