Pharmacology CH. 1 Intro to Drugs

The branch of pharmacology that uses drugs to treat, prevent, and diagnose disease.
Pharmacotherapeutics (Clinical Pharm.)

Name given to the drug by the manufacturer.
Brand Name

Agency that regulates development and sale of drugs in US.
FDA

Chemicals that are introduced into body to bring about some sort of change.
Drugs

Original designation that a drug is given when the drug company that developed it applies for the approval process.
Generic Name

Process of altering DNA, usually of bacteria, to produce a chemical to be used as a drug.
Genetic Engineering

Helpful in treating rare diseases and have not been “adopted” by any drug companies.
Orphan Drugs

Study of biological effects of chemicals.
Pharmacology

Having adverse effects on the fetus.
Teratogenic

Divided into 5 schedules by the DEA based on their potential for abuse or dependence.
Controlled Drugs

Lab animals tested for the effects of drugs on live tissue.
Preclinical Trials

Uses human volunteers to test the drugs, usually young men.
Phase 1 Study

Allows clinical investigators to try out the drug in patients who have the disease that the drug is designed to treat.
Phase 2 Study

Involves use of drug in a vast clinical market.
Phase 3 Study

After a drug is approved for marketing, it enters a phase of continual evaluation.
Phase 4 Study

Further regulate the distribution and administration of drugs.
Local Laws

Adequate studies in pregnant women have not demonstrated a risk to the fetus in the first trimester of pregnancy and there is no evidence of risk in later trimesters.
Category A

Animal studies have not demonstrated a risk to the fetus but there is no adequate studies in pregnant women.
Category B

Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans.
Category C

There is an evidence of human fetal risk, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
Category D

Studies in animals or humans demonstrate fetal abnormalities or adverse reaction.
Category X

High abuse potential and no accepted medical use. (Heroin, marijuana, LSD)
Schedule 1

High abuse potential with severe dependence liability. (narcotics, amphetamines, barbiturates)
Schedule 2

Less abuse potential than Schedule 2 drugs and moderate dependence liability. (Non-barbiturate sedatives, non-amphetamine stimulants, limited amounts of certain narcotics)
Schedule 3

Less abuse potential than schedule 3 and limited dependence liability. (Some sedatives, anti-anxiety agents, nonnarcotic analgesics)
Schedule 4

Limited abuse potential.
Schedule 5

Drugs no longer protected by patent and can be produced by companies other than the one that developed it.
Generic Drugs

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