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Behav. Sci. 2018, 8(1), 17; doi:10.3390/bs8010017

Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase

Cuban Council of Veterinary Sciences, Paseo 604 Vedado CP, La Habana 10400, Cuba
Received: 7 December 2017 / Revised: 17 January 2018 / Accepted: 18 January 2018 / Published: 24 January 2018
(This article belongs to the Special Issue State of Art in Non-Clinical Models for Neurodegenerative Diseases)
View Full-Text   |   Download PDF [191 KB, uploaded 24 January 2018]

Abstract

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). View Full-Text
Keywords: non-clinical; translational medicine; first-in-human drug use non-clinical; translational medicine; first-in-human drug use
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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Martínez Muñoz, L. Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase. Behav. Sci. 2018, 8, 17.

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