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PHARM chp 1
Term | Definition |
---|---|
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 |