2_Pharma Interactions Flashcards
what are the stages of clinical trials?
pre clinical, 1, 2, 3, FDA, 4
pre clinical trials are trials using:
not people (animals, petri dishes)
there are ______ compounds that are tested for every ____ that is approved by the FDA
5,000 to 1 (only 1000 ever make it to humans)
What stages are used on people?
1,2,3
it takes approximately ____ years to get a drug to be approved by the FDA
15 years
total cost of getting 1 drug produced?
1 billion
stage one is when you ____ and you only care about _____
when you start giving it to people WHO ARE HEALTHY, you don’t care if it works, only if it’s safe, what should the dose be, and how is it metabolized
phase 2 is:
slightly larger than 1, you start wondering if it’s effective and PEOPLE WHO ACTUALLY HAVE THE DISEASE
phase 3:
you increase the sample size and start comparing it to the standard therapy, evaluate the risks
it usually takes ___ stage ____ trials to bring the drug to market
2 stage 3 trials
phase 4 is ______ , and can test:
after it comes to market, “lets see how it works for this subset of the population with this certain disease” etc
stage 1 ______
safety, dosage, pharmacokinetics; HEALTHY PEOPLE
Stage 2:
effectiveness and possible short term side effects, PEOPLE WITH DISEASE, 200-300, double blind study to test safety and efficacy of drug x bs placebo in patients with hypertension
Stage 3:g
decided dose that will be given to FDA, how effective, side effects, longer study, 100s to 1000s and tested against the effectivelness of Another FSDA approved drug
Example of 2:
200 people in 2x (double) blind study to teest efficay of drug x vs placebo
