Flashcards in 1: Drug Development Deck (10)
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1
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
2
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
3
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?
4
describe phase 2 of clinical testing
-100-200 subjects
-does it work in patients?
5
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)
6
describe phase 4: marketing
-postmarketing surveillance until about year 20
-patient expires 20 years after filing of application -> generics become available
7
Pure Food and Drug Act
-1906
-due to "The Jungle" outcry
-insures purity and proper labeling
8
Federal Food, Drug and Cosmetic Act
-1938
-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
9
Kefauver-Harris Amendments
-1962
-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
-advertising
-established FDA authority over manufacturing
10
