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PHARM chp 1

adverse effects drug effects that are not the desired therapeutic effects; may be unpleasant or even dangerous
brand name name given to a drug by the pharmaceutical company that developed it; also called a trade name
chemical name name that reflects the chemical structure of a drug
drugs chemicals that are introduced into the body to bring about some sort of change
Food and Drug Administration (FDA) federal agency responsible for the regulation and enforcement of drug evaluation and distribution policies
generic drugs drugs sold by their generic name; not brand (or trade) name products
generic name the original designation that a drug is given when the drug company that developed it applies for the approval process
genetic engineering process of altering DNA, usually of bacteria, to produce a chemical to be used as a drug
orphan drugs drugs that have been discovered but would not be profitable for a drug company to develop; usually drugs that would treat only a small number of people; these orphans can be adopted by drug companies to develop
over-the-counter (OTC) drugs drugs that are available without a prescription for self-treatment of a variety of complaints; deemed to be safe when used as directed
pharmacology the study of the biological effects of chemicals
pharmacotherapeutics clinical pharmacology—the branch of pharmacology that deals with drugs; chemicals that are used in medicine for the treatment, prevention, and diagnosis of disease in humans
phase I study a pilot study of a potential drug done with a small number of selected, healthy human volunteers
phase II study a clinical study of a proposed drug by selected physicians using actual patients who have the disorder the drug is designed to treat; patients must provide informed consent
phase III study use of a proposed drug on a wide scale in the clinical setting with patients who have the disease the drug is thought to treat
phase IV study continual evaluation of a drug after it has been released for marketing
preclinical trials initial trial of a chemical thought to have therapeutic potential; uses laboratory animals, not human subjects
teratogenic having adverse effects on the fetus
Drugs are chemicals that are introduced into the body to bring about some sort of change
Drugs can come from many sources plants, animals, inorganic elements, and synthetic preparations
The FDA regulates the development and marketing of drugs to ensure safety and efficacy
Preclinical trials involve testing of potential drugs on laboratory animals to determine their therapeutic and adverse effects
Phase I studies test potential drugs on healthy human subjects
Phase II studies test potential drugs on patients who have the disease the drugs are designed to treat
Phase III studies test drugs in the clinical setting to determine any unanticipated effects or lack of effectiveness
FDA pregnancy categories indicate the potential or actual teratogenic effects of a drug
DEA controlled-substance categories indicate the abuse potential and associated regulation of a drug
Generic drugs are sold under their generic names, not brand names; they may be cheaper but in some situations are not necessarily as safe as brand-name drugs
Orphan drugs are chemicals that have been discovered to have some therapeutic effect but that are not financially advantageous to develop into drugs
OTC drugs are available without prescription for the self-treatment of various complaints
Information about drug sources the drug label, reference books, journals, and Internet sites
Created by: 1480781538



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