Lec 10 Flashcards
1
Q
what do phase 1 trials consist of?
A
several month study
limitation of eligible participants
Randomized double-blind placebo-control studies
dosing based on animal data
2
Q
what are the 2 approaches to dosing in phase 1?
A
SAD (single ascending dose) and MAD (Multiple ascending dose)
3
Q
what are the 2 approaches to dosing in phase 1?
A
SAD (single ascending dose) and MAD (Multiple ascending dose)
4
Q
what does phase 2 trials consist of?
A
exploring the therapeutic effect
minimize patients exposed to ineffective or toxic treatments
100-500 patients
5
Q
what does phase 3 consist of?
A
is the treatment beneficial to a specific population
establishment of side effects
6
Q
what is phase 4?
A
Post-market surveillance
monitor safety of drugs
