drug testing Flashcards
william withering
identify foxglove plant
trial on small group of patients with disease
trial on larger group- dosage
results recorded and published
active ingredient in foxglove
digitalin
pre- clinical trials
lab testing on animals or cell cultures.
assess safety and determine effectiveness
phase 1- clinical trial
small group of healthy volunteers
identify side effects
trial diff doses to find safe and effective dosage
phase 2 - clinical trial
small group of patients (100-300) test if drug works
phase 3 - clinical trial
double blind trial
larger group (1000-3000)
randomly assigned
test group given drug control gorup given placebo
check efficacy and side ffects
improve validity
after licencing
drug licenced, data no efficacy and safety continue to be monitored
placebo
inactive compiund
double blind trial
neither doctor or patient know if they are giving group drug or placebo.
prevents psychosomatic influence