Phase 1 clinical trials involve small groups of healthy volunteers to determine safety and side effects. Phase 2 trials enroll larger patient groups to study effectiveness and further monitor safety. Phase 3 trials involve even more patients to confirm effectiveness, monitor side effects, compare to standard treatments, and collect information to allow safe use. Post-marketing surveillance occurs after FDA approval to continue monitoring safety in large populations over long periods of time.

1. Quiz semi 1
I. IDENTIFY THE FOLLOWING:
1. A stage where Efficacy and adverse drug reactions monitored? Phase 3
2. Expresses the full story of a drug molecule? NDA new drug application
3. These trials are conducted on larger groups of patients and are aimed to evaluate the efficacy of the drug? phase 2
4. Are conducted in people (volunteer)and intended to answer specific questions about the safety and efficacy of
drugs, vaccines, other therapies, or new methods of using current treatments? Clinical trials
5. Trials with a lesser number of healthy human volunteers. In most cases, 20 to 80 healthy volunteers with the
disease/condition? Phase 1
6. Trials besides termed as human micro dose studies, they have single sub-therapeutic doses given to 10 to 15
volunteers and give pharmacokinetic data or help with imaging specific targets without exerting pharmacological
action? Phase 0
7. An international ethical and scientific standard for conducting biomedical and behavioral research involving human
participants. Good Clinical Practice
8. Independent body established to protect the rights and welfare of human research participants. Institutional
Review Board
9. A process by which a person voluntarily agrees to participate in a research study after being fully informed about it.
Informed Consent
10. Untoward medical occurrence” in a person who receives a drug while participating in a clinical study? ADVERSE
EVENT
II. Supply the information below: 5 POINTS EACH
PHASE
0/LABORATORY
PHASE I Phase II PHASE III PHASE IV