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 |