Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase
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...
Paper Details
Title
Non-Clinical Contribution to Clinical Trials during Lead Optimization Phase
Published Date
Jan 24, 2018
Journal
Volume
8
Issue
1
Pages
17 - 17
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