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Use of biomarkers for assessing radiation injury and efficacy of countermeasures

Several candidate drugs for acute radiation syndrome (ARS) have been identified that have low toxicity and significant radioprotective and radiomitigative efficacy. Inasmuch as exposing healthy human volunteers to injurious levels of radiation is unethical, development and approval of new radiation...

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Autores principales: Singh, Vijay K, Newman, Victoria L, Romaine, Patricia LP, Hauer-Jensen, Martin, Pollard, Harvey B
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Taylor & Francis 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732464/
https://www.ncbi.nlm.nih.gov/pubmed/26568096
http://dx.doi.org/10.1586/14737159.2016.1121102
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author Singh, Vijay K
Newman, Victoria L
Romaine, Patricia LP
Hauer-Jensen, Martin
Pollard, Harvey B
author_facet Singh, Vijay K
Newman, Victoria L
Romaine, Patricia LP
Hauer-Jensen, Martin
Pollard, Harvey B
author_sort Singh, Vijay K
collection PubMed
description Several candidate drugs for acute radiation syndrome (ARS) have been identified that have low toxicity and significant radioprotective and radiomitigative efficacy. Inasmuch as exposing healthy human volunteers to injurious levels of radiation is unethical, development and approval of new radiation countermeasures for ARS are therefore presently based on animal studies and Phase I safety study in healthy volunteers. The Animal Efficacy Rule, which underlies the Food and Drug Administration approval pathway, requires a sound understanding of the mechanisms of injury, drug efficacy, and efficacy biomarkers. In this context, it is important to identify biomarkers for radiation injury and drug efficacy that can extrapolate animal efficacy results, and can be used to convert drug doses deduced from animal studies to those that can be efficacious when used in humans. Here, we summarize the progress of studies to identify candidate biomarkers for the extent of radiation injury and for evaluation of countermeasure efficacy.
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spelling pubmed-47324642016-02-16 Use of biomarkers for assessing radiation injury and efficacy of countermeasures Singh, Vijay K Newman, Victoria L Romaine, Patricia LP Hauer-Jensen, Martin Pollard, Harvey B Expert Rev Mol Diagn Reviews Several candidate drugs for acute radiation syndrome (ARS) have been identified that have low toxicity and significant radioprotective and radiomitigative efficacy. Inasmuch as exposing healthy human volunteers to injurious levels of radiation is unethical, development and approval of new radiation countermeasures for ARS are therefore presently based on animal studies and Phase I safety study in healthy volunteers. The Animal Efficacy Rule, which underlies the Food and Drug Administration approval pathway, requires a sound understanding of the mechanisms of injury, drug efficacy, and efficacy biomarkers. In this context, it is important to identify biomarkers for radiation injury and drug efficacy that can extrapolate animal efficacy results, and can be used to convert drug doses deduced from animal studies to those that can be efficacious when used in humans. Here, we summarize the progress of studies to identify candidate biomarkers for the extent of radiation injury and for evaluation of countermeasure efficacy. Taylor & Francis 2016-01-02 2015-12-08 /pmc/articles/PMC4732464/ /pubmed/26568096 http://dx.doi.org/10.1586/14737159.2016.1121102 Text en © 2015 The Author(s). Published by Taylor & Francis. http://creativecommons.org/licenses/by-nc-nd/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.
spellingShingle Reviews
Singh, Vijay K
Newman, Victoria L
Romaine, Patricia LP
Hauer-Jensen, Martin
Pollard, Harvey B
Use of biomarkers for assessing radiation injury and efficacy of countermeasures
title Use of biomarkers for assessing radiation injury and efficacy of countermeasures
title_full Use of biomarkers for assessing radiation injury and efficacy of countermeasures
title_fullStr Use of biomarkers for assessing radiation injury and efficacy of countermeasures
title_full_unstemmed Use of biomarkers for assessing radiation injury and efficacy of countermeasures
title_short Use of biomarkers for assessing radiation injury and efficacy of countermeasures
title_sort use of biomarkers for assessing radiation injury and efficacy of countermeasures
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732464/
https://www.ncbi.nlm.nih.gov/pubmed/26568096
http://dx.doi.org/10.1586/14737159.2016.1121102
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