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Description

Starting at a lower dose allows tissues to respond without overstimulation, then the higher dose in Phase 2 extends and deepens that response

When multiple administration is employed, split dosing regimens such as those described herein may be used

Requirements of a First in Human Clinical Trial A First in Human clinical trial must meet specific requirements, including: Data on the Quality of the Investigated Drug Thorough evaluation of the pharmaceutical formulations quality is essential before commencing the clinical trial