Emphasized Topics Flashcards
What are the first 3 steps of the drug approval process?
- Discovery (synthesis)
- Preclinical Research (testing for pharma activity + toxicity)
- Apply for Investigational New Drug Application (<0.01% make it here)
What is Phase I of drug approval process?
Testing for toxicity/tolerance at different doses.
How is Phase I testing done?
Small # of health subjects OR people with the disease who have no other alternatives
How long does Phase I take?
1-2.5 years
What is Phase II?
Gathering the initial efficacy evidence and looking for cumulative toxic effects
How is Phase II performed?
Trials in patients with the condition/disease
How long does Phase II take?
2-3 years
What is Phase III?
Getting rigorous evidence of efficacy to identify major adverse reactions
How is Phase III investigated?
- Double-blind, controlled, randomized trials
- Must show comparisons to existing standards
- Must show statistically significant effect for pre-established clinical endpoints
How many trials does Phase III have?
2 trials, at least 1 in the US
How long does Phase III take?
3+ years
Overview of the Drug Approval system?
- Discovery
- Preclinical
IND
I. Safety
II. Efficacy/Does it work
III. How does it compare
What are the insurance trends?
Medicare:
- Medicare Advantage growing
Medicaid:
- Medicaid enrollment increased b/c of expanded enrollment during COVID, now going through disenrollment
- overall growing b/c last few states expanding
Marketplace:
- ACA marketplace enrollment at all time high
Private:
- moving towards managed care/ value based care instead of FFS = managed care by PPO or HMO (primary care controlling)
Which countries use cost-effectiveness in terms of government entities?
Australia, Norway, UK
NOT Germany, US
