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
Descripción
Sumario: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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