Clinical Research Presentation
10,000 compounds narrowed down to one usable drug (after FDA approval that takes 1-2 years)
Safety of the Subjects is #1
Researcher must define ALL possible adverse events
1) Pre-clinical Research on animals
[cardiovascular studies - done on pigs & and immuniology - done on lab rats]
2) A. phase 1: in-patient setting of healthy subjects that are usually monitored continuously
B. phase 2: most commonly done in out-patient setting - disease state subjects
C. phase 3: disease state subjects - wide/diverse population
3) All data is sent to FDA for approval
4) Phase 4: extra step - given to disease state subjects for free to promote drug
Sponsor: holder of drug patent
$Doctor makes Bank$ for including new drug in treatment plan of patients!
Efficacy- degree the drug works if it is taken like it is supposed to be.