level: Phases of Clinical Trials
Questions and Answers List
level questions: Phases of Clinical Trials
| Question | Answer |
|---|---|
| This phase emphasizes safety, it involves 20 to 80 healthy volunteers, information on the drugs most adverse effects. to study potential toxicity | Phase I trial |
| Drug is given to 100-300 volunteers w/ disease to determine drug’s effectivity | Phase 2 trial |
| 1-3k volunteers w/ specific disease & in hospitals to monitor S/E & to confirm effect & safety | Phase 3 trial |
| If phase III trial is succesful, the sponsor applies for what? | New Drug Application to the FDA |
| This phase happen after FDA has approved the drug | Phase IV post marketing |