Intro Flashcards
What is a drug
any chemical that can affect living processes
What are pharmocotherapeutics
the use of drugs to diagnose, prevent, or treat disease
the desired therapeutic effect of the drug
Preclinical testing
only done in animals
focused on toxicity and pharmokinetics
Phase1 testing
done on healthy volunteers
looking how drug is mestabolized and moves trhough the body
phase 2 teasting
done on patients
focus is terapeutic utility and dose range
phase 3 testing
done on patients, focus on safety and effectiveness
phase 4 testing
postmoarketing surevillance, countinues public monitoring
Why were women originallly banned from phase 1/2 until 1980
concerns about effecting fertility
when are children included
only if they have disease
Pure food and drug act
1906
first law to regulate drugs, quality, purity and strength
shirley amendment
prohibited manufacturers from labeling medicine with false claims
Druham-humphrey amendment
any drug that is habit forming had to be prescribed
controls what is a med that needs to be prescribes
Kefauver-harris amendment
drugs need to be proven to be effective before they can be marketed
Controlled substance act
set rules about distribution of drugs that can cause dependence, like narcotics
The schedule classifications
Schedule 1
no recognized medical use, high abuse potential
Heroin, LSD, meth
schedule 2
written prescriptions required, cannot be done over the phone
codeine, morphine, amphetemines
schedule 3
prescriptions required ro be rewritten after 6 months or 5 refills
lower amounts of codeine, butabarbital
schedule 4
prescriptions required to be rewritten after 6 months after 6 months or 5 refills
Pentaazocine
Schedule V
dispensed as any nonnarcotic prescription
Category A
no risk to fetus in first trimester of ppregnancy
Category B
animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in women
category C
animal reproducction studies have shown addverse effect in fetus and there are no studies in humans, BUt potential benefit may outweighg risks
category D
there is positive edidence of human fetal risk based on human studies, but potential benefits may warrant use of drug in pregnant women
category X
proven risk, benefits to no outweigh cost, would not give to pregnant women