Drug Development and Testing Flashcards
How long does it take to develop a drug, on average?
15 years
How much does it cost to develop a drug, on average?
$360 million
How many new compounds actually reach the market? Of the ones that reach the market, how many actually return on investment?
2 in 10.
3 out 10 that reach the market actually make a ROI
What are the four phases of drug development and testing?
Phase 1 - test for safety in normal people (20-80)
Phase 2 - test safety and effectiveness in several HUNDRED people
Phase 3 - test safety, dosage, effectiveness, and adverse event in several THOUSAND people
Phase 4 - post-marketing surveillance for adverse event monitoring
What is a scientific/chemical name of a drug?
Name determined by its chemical structure
What is a generic name of a drug? Are generic names capitalized?
Before any drug is marketed it is given an official generic name approved by USAN Counciil.
Generic names are not capitalized
What is a brand/trade name of a drug?
Initially only the discovering pharma company gives it a trade name, which only it can use. After patent expiration there can be other trade names, which are protected from being used by other companies
What is the margin of safety?
LD50/ED50. If LD50 = 10 mg and ED50 = 2, then the margin of safety is only 5.
What does a margin of safety of 5 mean?
Means that the the lethal doseis only 5 times the effective dose
What is the acceptable margin of safety?
2000 or more
Which pieces of legislation regulate drug marketing and safety?
Pure Food and Drug Act of 1906 - created FDA; correct/truthful labeling
Food, Drug and Cosmetic Act of 1938 - proof of drugs safety and purity
FDA Modernization Act of 1997 - off label use, accelerated approval for life-threatening medical disorders
Which Act grants the FDA authority to determine which drugs may be sold w/out a prescription?
Durham-Humphrey Act of 1952
Which Act requires proof of efficacy as well as safety for new drugs and drugs approved since 1938?
1962 Kefauver-Harris Amendments to the Food, Drug and Cosmetic Act
What authority does the FDA have over OTC drugs and dietary supplements?
OTC - ability of someone to self-diagnose; lower dose than Rx counterparts; primarily to treat Sx ; Durham-Humphrey Act of 1952
Supplements - FDA does NOT evaluate efficacy; FDA must demonstrate that a supplement is unsafe before taking action against it; Dietary Supplement Health ad Education Act of 1994; Federal Food, Drug, and Cosmetic Act of 2006 industry must report to FDA any adverse drug events
