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30 Cards in this Set
- Front
- Back
Preclinical trials
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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.
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Teratogenic
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Causing adverse effects to the fetus
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Phase I studies
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Use human volunteers to test the drugs. Usually young men.
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Phase II studies
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Allow clinical investigators to try the drugs in patients who have the disease that the drug is meant to treat.
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Phase III studies
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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.
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Brand name
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trade name developed by the pharmaceutical company that developed it.
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Generic name
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origianl designation that the drug was given when the drug company applied for the approval process.
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Chemical name
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are names that reflect the chemical structure of a drug.
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Phase IV study
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continual evaluation
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Category A
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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.
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Category B
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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.
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Category C
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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.
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Category D
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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.
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Category X
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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.
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Schedule I
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High abuse potential and no accepted medical use (heroine, marijuana, LSD)
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Schedult II
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High abuse potential with severe dependence liability (narcotics, amphetamines, and barbituates)
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Schedule III
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Less abuse potential than Schedule II drugs and moderate dependence liability (nonbarbiturate sedatives, nonamphetamine stimulants, limited amounts of certain narcotics)
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Schedule IV
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Less abuse potential than Schedule III and limited dependence liability (some sedatives, antianxiety agents, and non narcotic analgesics)
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Schedule V
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Limited abuse potential. Primarily small amounts of narcotics (codeine)
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pharmacodynamics
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how the drug affects the body
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pharmacokinetics
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how the body acts on the drug
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pharmacology
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the study of the biological effects of chemicals
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pharmacotherapeutics
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clinical pharmacology, the branch of pharmacology that uses drugs to treat, prevent, and diagnose disease.
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genetic engineering
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the process of altering DNA
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Orphan drugs
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drugs that have been discovered but are not financially viable and therefore have not been "adopted" by any drug company.
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chemotherapeutic agents
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interfere with the functioning of foreign cells, such as invading microorganisms or neoplasms.
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selective toxicity
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The ability of a drug to attack only those systems found in foreign cells .
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critical concentration
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the amount of a drug that is needed to cause a therapeutic effect.
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Absorption
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what happens to a drug from the time it is introduced to the body until it reaches the circulating fluids and tissues.
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Passive diffusion
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major process through which drugs are absorbed into the body. Occurs across a concentration gradient.
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