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30 Cards in this Set

  • Front
  • Back
Preclinical trials
chemicals that may have therapeutic value are tested on lab animals for 2 main purposes. 1. determine whether they have the presumed effects in living tissue, and 2. evaluate any adverse effects.
Teratogenic
Causing adverse effects to the fetus
Phase I studies
Use human volunteers to test the drugs. Usually young men.
Phase II studies
Allow clinical investigators to try the drugs in patients who have the disease that the drug is meant to treat.
Phase III studies
involve use of the drug in vast clinical market. Prescribers then evaluate the reported effects to determine whethey they are caused by the disease or by the drug.
Brand name
trade name developed by the pharmaceutical company that developed it.
Generic name
origianl designation that the drug was given when the drug company applied for the approval process.
Chemical name
are names that reflect the chemical structure of a drug.
Phase IV study
continual evaluation
Category A
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 B
Animal studies have not demonstrated a risk to the fetus but there are no adequate studies in pregnant women, or animal studies have shown an adverse effect.
Category C
Animal studies have shown an adverse effect on the fetus but there are no adequate studies in humans; the benefits from the use of the drug in pregnant women may be acceptable despite it's potential risk, or there are no adequate studies in humans.
Category D
There is no 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 X
Studies in animals or humans demonstrate fetal abnormalities or adverse reaction; reports indicate evidence of fetal risk. The risk of use in a pregnant woman clearly outweighs any possible benefit.
Schedule I
High abuse potential and no accepted medical use (heroine, marijuana, LSD)
Schedult II
High abuse potential with severe dependence liability (narcotics, amphetamines, and barbituates)
Schedule III
Less abuse potential than Schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)
Schedule IV
Less abuse potential than Schedule III and limited dependence liability (some sedatives, antianxiety agents, and non narcotic analgesics)
Schedule V
Limited abuse potential. Primarily small amounts of narcotics (codeine)
pharmacodynamics
how the drug affects the body
pharmacokinetics
how the body acts on the drug
pharmacology
the study of the biological effects of chemicals
pharmacotherapeutics
clinical pharmacology, the branch of pharmacology that uses drugs to treat, prevent, and diagnose disease.
genetic engineering
the process of altering DNA
Orphan drugs
drugs that have been discovered but are not financially viable and therefore have not been "adopted" by any drug company.
chemotherapeutic agents
interfere with the functioning of foreign cells, such as invading microorganisms or neoplasms.
selective toxicity
The ability of a drug to attack only those systems found in foreign cells .
critical concentration
the amount of a drug that is needed to cause a therapeutic effect.
Absorption
what happens to a drug from the time it is introduced to the body until it reaches the circulating fluids and tissues.
Passive diffusion
major process through which drugs are absorbed into the body. Occurs across a concentration gradient.