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study of drugs and their actions on living organisms

Food and drug adminstration (FDA),

Who is responsible for approving new drugs and monitoring drugs for adverse or toxic effects

drug development

takes 7 to 12 years


manufacturer develops a drug that has potential
invitro testings on animal and human cells
live animals
then applies for IND (INVESTIGATIONAL NEW DRUG) status

drug testing phase involes 3 phases

phase 1
last 4 to 6 weeks
done on 20-100 healthy volunteers
phase 11
phase 111
studies focus on dosing and safety

NDA New drug application

this is submitted after phase 1, 11, and 111, are completed and the drug is found to be safe and effective

special FDA programs

Orphan drug program
compassionate access to unapproved drugs

What are the four different drug names?


drug categories

prescription, nonprescription, controlled substance

prescription drugs

federal government has stated they are potentially harmful unless their use is under supervision of a health care professional
know as legend drugs
must be prescribed by a licensed health care provider

the prescription must contain?

name of drug
the dosage
the method and times for administration
signature of a licensed health care provider

non-prescription drugs

are designated by the FDA to be safe if taken as directed
no prescription required
can also be called OTC over-the-counter

controlled substance

are the most carefully monitored of all drugs
high potential for abuse
may cause physical or psychological dependence

physical dependence

a compulsive need to use a substance repeatedly to avoid mild to severe withdrawal symptoms

psychological dependence

a compulsion to use a substance to obtain a pleasurable experience
it is the mind's dependence

controlled substance act of 1970

regulates the manufacture, distribution and dispensing of drugs that have abuse potential

controlled substances act of 1970

classified into shcedules (CI, CII, CIII, CIV, CV)
based on their potential for abuse and physical and psychological dependence

controlled substances scheduled C1

high abuse potential
not accepted in US
Heroin, marijauana, ecstasy, LSD

the prescription for controlled substances must contain?

must be in ink
cannot be filled more than 6 months after the prescription was written
cannot be refilled more than 5 times

controlled substances scheduled C11

high potential for abuse
demerol, methadone, morphine, oxycontin, amphetamines, ritalin

controlled substances scheduled C111

less potential for abuse than C11
potential for moderate abuse
vicodin, Tylenol#3

controlled substances scheduled C1V

less potential for abuse than C111
anxiety meds

controlled substances scheduled CV

limited abuse potential
mainly antitussives and antidiarrheals


urine, sweat, breast milk, breathing, feces


the process of chemical reactions where the liver converts a drug to inacative compounds

Pharmacodynamic phase

the drug's actions and effects within the body

anaphylactic shock

serious allergic drug reaction
requires immediate medical attention
can be fatal if not treated immediately

drug idiosyncrasy

any unusal or abnormal reaction to a drug

drug tolorence

a sign of drug dependency

cumulative drug effect

when the body is unable to metabolize and excrete one dose of a drug before the next is given

can occur in patient with liver or kidney disease

Half Life

the time required for the body to eliminate 50% of the drug in circlulation
takes 5 to 6 half-lives to eliminate the drug completely from the body

drug-food interaction

empty stomach vs full stomach
dairy products
certain fruits and vegies

factors influencing drug response

route of administration

drug-drug ineraction

one drug effecting the potency of another drug

drug-drug ineraction

additive drug reaction
synergistic drug reaction
antagonist drug reaction

antagonist drug reaction

one drug working against another drug or blocking the drugs effectiveness

synergistic drug reaction

two drugs working together in harmony being better then one drug working alone

additive drug reaction

the combined effect of two drugs equals the sum of the effects of each drug given alone

toxic reactions

can be reversible or irriversible depending on the organs involved

Which drugs interact or interferes with the action of another drug?

oral anticoagulants
oral hypoglycemics
cardiac glycosides


a genetically caused abnormal response to normal doses of a drug
due to inherited traits

drug reaction

adverse reaction-undesirable drug effect
allergic reaction-a drug reaction that occurs because the individual's immune system views the drug as a foreign substance

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