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 |