level: Phases of New Drug Development
Questions and Answers List
level questions: Phases of New Drug Development
| Question | Answer |
|---|---|
| The drug is tested on healthy volunteers | Phase I |
| involves trials with people who have the disease for which the drug is thought to be effective. | Phase II |
| large number of patients in medical research centers receive the drug provides information about infrequent or rare adverse effects FDA will approve a new drug application if satisfactory | Phase III |
| voluntary and involves postmarket surveillance of the drug's therapeutic effects at the completion of phase III. | Phase IV |
| Exceptions to the Rule | 1 Public health threat of disease like AIDS, COVID-19 2 Sponsors of drugs that reach phase II or III clinical trials can apply for FDA approval of treatment IND status |