Drug development is a lengthy and high-risk process that demands significant resource investment.With drug safety being unpredictable,approximately 75%of the expenses linked to drug development failures arise during the early stages of clinical trials.Phase 0 clinical trials involve administering"microdoses"to swiftly gather essential data on human pharmacokinetics and pharmacodynamics,thereby conserving resources and enhancing the success rates of subsequent trials.However,in China,phase 0 clinical research is still in its nascent stages,lacking corresponding regulations,guidelines,well-designed studies,and adequately trained researchers.This paper presents a comprehensive overview of the importance,current obstacles,suggested solutions,and effective strategies concerning phase 0 clinical research in innovative drug development,aiming to introduce a new approach to original drug research and development in the country.
phase 0 clinical trial/exploratory IND studiesoriginal drug developmentnuclide labeling and imagingorgan chip
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