Chapter 1 Flashcards
Aluminum, fluoride, iron and gold are what type of compound
Inorganic compound
What is the purpose of the FDA?
Regulates the development of and sale of drugs
For every 100,000 potential drugs, how many become actual drugs?
5
Preclinical trials- Phase 1- Phase 2- Phase 3 Phase 4-
Preclinical trials- animals
Phase 1- human volunteers, men
Phase 2- actually patients that have a the disease
Phase 3- wide scale use with patients that have the disease
Phase 4- continual evaluation of the drug and therapeutic effects
What is used for insulin production
Escherichia coli
What is the purpose of the controlled substance act of 1970
2 reasons
Ranking the abuse potential
Function of the FDA?
Regulates the development and sale of the drugs
Category A Category B Category C Category D Category X
Category A - no risk to fetus in first trimester
Category B - no fetus risk with animals,no studies with pregnant women
Category C - adverse effects in animals fetuses
Category D - evidence of human fetal risk
Category X - never used in pregnancy
Schedule 1
Street drugs. no medical use
Schedule 2
Highs abuse potential, narcotics, amphetamines, barbiturates
Schedule 3
Less abuse potential than schedule 2,
NOn barbiturate, Nonamphetamines
Schedule 4
Limited dependence liability
Schedule 5
Small amounts of narcotics, purchased without a prescription must be 18 years old
Orphan drugs
Not financially available, not adopted by drug companies
Limited market or narrow margin of safety