1: Drug Development Flashcards
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
- 1906
- due to “The Jungle” outcry
-insures purity and proper labeling
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
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
FDA Modernization Act
- 1997
- 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
