Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase

This manuscript comments on guidelines related to requirements for clinical trials for new drugs and the importance of considering regulatory criteria in the planning phase, in order to enhance the utility of data generated in basic research. Suggestions are made for optimizing regulatory management...

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Detalles Bibliográficos
Autor principal: Martínez Muñoz, Lázara
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2018
Materias:
Conference Report
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791035/
https://www.ncbi.nlm.nih.gov/pubmed/29364181
http://dx.doi.org/10.3390/bs8010017
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author Martínez Muñoz, Lázara
author_facet Martínez Muñoz, Lázara
author_sort Martínez Muñoz, Lázara
collection PubMed
description This manuscript comments on guidelines related to requirements for clinical trials for new drugs and the importance of considering regulatory criteria in the planning phase, in order to enhance the utility of data generated in basic research. Suggestions are made for optimizing regulatory management to improve the likelihood of acceptance of pre-clinical data prior to Clinical Phase I trials (early clinical trials).
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spelling pubmed-57910352018-02-05 Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase Martínez Muñoz, Lázara Behav Sci (Basel) Conference Report This manuscript comments on guidelines related to requirements for clinical trials for new drugs and the importance of considering regulatory criteria in the planning phase, in order to enhance the utility of data generated in basic research. Suggestions are made for optimizing regulatory management to improve the likelihood of acceptance of pre-clinical data prior to Clinical Phase I trials (early clinical trials). MDPI 2018-01-24 /pmc/articles/PMC5791035/ /pubmed/29364181 http://dx.doi.org/10.3390/bs8010017 Text en © 2018 by the author. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (http://creativecommons.org/licenses/by/4.0/).
spellingShingle Conference Report
Martínez Muñoz, Lázara
Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase
title Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase
title_full Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase
title_fullStr Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase
title_full_unstemmed Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase
title_short Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase
title_sort non-clinical contribution to clinical trials during lead optimization phase
topic Conference Report
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791035/
https://www.ncbi.nlm.nih.gov/pubmed/29364181
http://dx.doi.org/10.3390/bs8010017
work_keys_str_mv AT martinezmunozlazara nonclinicalcontributiontoclinicaltrialsduringleadoptimizationphase

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