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describe the pre-clinical phase, years 0-2

in vitro studies: testing biologic compounds (naturally in the body) and doing chemical synthesis and optimization until a lead compound is found


describe the pre-clinical phase, years 3-4

animal testing: test efficacy, selectivity, and mechanism of the lead compound

-at the end of this phase, called an IND = investigational new drug -> file when you reach the end of this to get the right to move into clinical trials


describe phase 1 of clinical testing

-20-100 subjects
-asks: is it safe? what are the pharmacokinetics (what dose is tolerable/ how long does it stay metabolically active/where does it go?


describe phase 2 of clinical testing

-100-200 subjects
-does it work in patients?


describe phase 3 of clinical testing

-1000-6000 subjects
-does it work? double blind?

at end of this stage, fill out NDA = new drug application to prove safe for humans and able to market (about years 8-9)


describe phase 4: marketing

-postmarketing surveillance until about year 20
-patient expires 20 years after filing of application -> generics become available


Pure Food and Drug Act

-due to "The Jungle" outcry

-insures purity and proper labeling


Federal Food, Drug and Cosmetic Act

-due to Sulfanilamide in diethylene glycol accident: the latter is a renal toxin that causes acidosis and renal failure - 100 people died (many children)

-requires toxicity studies for safety; enforced by FDA


Kefauver-Harris Amendments

-due to thalidomide causing phocomelia in babies when used by preggers for nausea/vomit

-required proof of efficacy
-established guidelines for reporting adverse effects
-clinical testing
-established FDA authority over manufacturing


FDA Modernization Act

-expedited review for drugs for serious diseases
-permitted marketing even before Phase 2 and 3 studies completed in some cases

ex: AIDS drug Indinivar approved in 42 days