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. 2018 Dec 15;10(12):4302–4312.

Table 1.

The pre-clinical and clinical trials in drug development

Contents Preclinical trials Clinical trials

Phase I Phase II Phase III Phase IV
Objects Lab study Human Human Human Human
In vitro assays 20-80 people 100-300 people >1000 people >1000 people
In vivo animals
Goal Effects Safety Efficacy Efficacy Efficacy
Safe Side effects Safety Safety Long-term safety
Dose Administration routes Side effects Side effects Side effects
Administration routes drug distribution etc Dose escalation Mortality rate
Time to last 1-3 years Months to years 1-2 years Several years Long-term
Chance to pass NA 70% 30% 25-30% Rare withdrawal