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Pharm - Pharm Legis

Medical Terminology

TermDefinition
Food and Drug Administration (FDA) government agency that evaluates the safety of drugs and regulating their testing, manufacturing, labeling, advertising, marketing, and efficacy
compassionate use IND application to the Food and Drug Administration (FDA) to allow physicians to prescribe an investigational drug before the FDA officially approves it (also known as Emergency Treatment Investigational New Drug Application)
postmarket surveillance Phase IV clinical trials that take place after the FDA has approved the drug for use
pharmaceutical drugs substances that have medicinal properties and affect the body function
off-label use prescription of drugs for uses other than those specified in the FDA approval
clinical trials human testing of a new drug
placebo a form of a drug that exerts no pharmacologic effect, has no therapeutic effect, and has no side effects when administered
control group group of patients in a clinical trial that receive the placebo form of the drug
experimental group group of patients in a clinical trial that receive the active form of the drug
double-blind study experiment in which neither the patients nor the investigators know which patients receive the drug and which patients receive the placebo
Durham-Humphrey Amendment the 1951 legislative act that defined prescription drugs as those drugs that could only be given to patients under the care of a physician
Food, Drug, and Cosmetic Act the 1938 United States law that requires that drug manufacturers provide scientific evidence of the safety of their products, bans false claims in drug labeling, and authorizes factory inspections
over-the-counter (OTC) drugs drugs that can be used without a prescription; the FDA approves these drugs as safe when used according to the label’s directions and warnings
prescription drug a drug that one can only obtain with a written prescription or verbal order from a physician or licensed health care provider
Kefauver-Harris Amendment the 1962 legislative act that required that manufacturers show drugs to be both safe and effective before marketing them
controlled substances drugs with potential for addiction, abuse, or dependence, which the Controlled Substances Act regulates
Controlled Substances Act the 1970 United States law that established the Drug Enforcement Administration (DEA) and divided potentially addictive drugs into five categories based on their potential for dependence
Drug Enforcement Administration (DEA) the government agency that enforces the Controlled Substances Act
schedule drugs drugs with potential for addiction, abuse, or dependence, regulated by the Controlled Substances Act
Schedule I drugs a type of drug with no known medicinal uses that is extremely addictive and not medically available
Schedule II drugs a type of drug with medicinal uses that is highly addictive and only available with a prescription
Schedule III drugs a type of drug with medicinal uses that is moderately to highly addictive and only available with a prescription
Schedule IV drugs a type of drug with medicinal uses that is moderately addictive and only available with a prescription
Schedule V drugs a type of drug with medicinal uses that is not very addictive and only available with a prescription
toxicology the study of harmful effects of drugs
frequency distribution curve a chart that describes the number of animals that respond to a drug at each dose
half-life the time required for the drug concentration in the blood to decrease from 100% to 50%
median effective dose (ED50) the dose of a drug that produces a therapeutic response in 50% of the animals tested
therapeutic index (TI) the ratio of the dose of a drug that produces a therapeutic effect and the dose that produces a lethal effect in animals (ED50/TD50)
median toxicity dose (TD50) the dose of a drug at which 50% of the animals tested have toxic levels of the drug
Created by: rleroux