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chapter3
| Question | Answer |
|---|---|
| abbreviated new drug application (aNDA) | the process by which applicants must scientifically demonstrate to the FDA that their generic product is bioequivalent to or performs in the same way as the innovator drug |
| active ingredient | the biochemically active component of the drug that exerts a desired therapeutic effect |
| addiction | compulsive and uncontrollable use of controlled substances, especially narcotics |
| adverse drug reaction (ADR) | a negative consequence to a patient from taking a particular drug |
| antibiotic | a chemical substance that is used in the treatment of bacterial infectious diseases and has the ability to either kill or inhibit the growth of certain harmful microorganisms |
| antibody | the part of the immune system that neutralizes antigens or foreign substances in the body |
| antineoplastic drug | a cancer-fighting drug |
| bactericidal | having the ability to destroy bacteria |
| bioavailability | the time it takes for a generic drug to reach the bloodstream in healthy volunteers |
| bioequivalent | a generic drug that delivers approximately the same amount of active ingredient into a healthy volunteer's bloodstream in the same amount of time as the innovator or brand name drug |
| biotechnology | the field of study that combines the sciences of biology, chemistry, and immunology to produce synthetic, unique drugs with specific therapeutic effects |
| black box warning | a warning statement required by the FDA indicating a serious or even life-threatening adverse reaction from a drug; the warning statement is on the product package insert (PPI) for the pharmacy staff and in the MedGuide for consumers |
| deoxyribonucleic acid (DNA) | the helix-shaped molecule that carries the genetic code |
| destructive agent | a drug that kills bacteria, fungi, viruses, or even normal or cancer cells |
| diagnostic agent | a chemical containing radioactive isotopes used to diagnose and treat disease |
| dietary supplement | a category of nonprescription drugs that includes vitamins, minerals, and herbals that are not regulated by the FDA |
| drug | any substance taken into or applied to the body for the purpose of altering the body's biochemical functions and thus its physiological processes |
| drug recall | the process of withdrawing a drug from the market by the FDA or the drug manufacturer for serious adverse effects or other defects in the product |
| drug tolerance | a situation that occurs when the body requires higher doses of a drug to produce the same therapeutic effect |
| FDA Online Orange Book | an online reference that provides information on the generic and therapeutic equivalence of drugs that may have many different brand names or generic manufacturer sources |
| generic drug | a drug that contains the same active ingredients as the brand name product and delivers the same amount of medication to the body in the same way and in the same amount of time; a drug that is not protected by a patent |
| genetic engineering | process of utilizing DNA biotechnology to create a variety of drugs |
| genome | the entire DNA in an organism, including its genes |
| good manufacturing practices (GMPs) | general principles and guidelines used during the manufacturing process to ensure a quality product |
| homeopathic medications | a class of drugs in which very small dilutions of natural drugs are taken to stimulate the body’s immune system |
| inert ingredient | an inactive chemical—such as a filler, preservative, coloring, or flavoring—that is added to one or more active ingredients to improve drug formulations while causing little or no physiological effect; also called an inactive ingredient |
| informed consent | a document that states, in easily understandable terms, the purpose and risks of the drug research |
| investigational new drug application (INDA) | process by which a manufacturer submits research results from animal studies to the FDA to gain approval to gather data and investigate a new drug in humans |
| MedGuide | written patient information mandated by the FDA for select high-risk drugs; also known as a patient medication guide |
| MedWatch | a voluntary program run by the FDA for reporting serious adverse events, product problems, or medication errors. |
| National Drug Code (NDC) number | a unique number assigned to a brand name, generic, or OTC product to identify the manufacturer, drug, and packaging size |
| over-the-counter (OTC) drug | a drug sold without a prescription |
| pharmaceutical alternative drug product | a drug product that contains the same active therapeutic ingredient but contains different salts or different dosage forms; cannot be substituted without prescriber authorization |
| pharmaceutically equivalent drug product | a drug product that contains the same amount of active ingredient in the same dosage form and meets the same USP-NF compendial standards (i.e., strength, quality, purity, and identity); can be substituted without contacting the prescriber |
| pharmacodynamic agent | a drug that alters body functions in a desired way |
| physical dependence | a state in which abruptly terminating a drug produces physical withdrawal symptoms such as restlessness, anxiety, insomnia, diarrhea, vomiting, and goose bumps |
| product package insert (PPI) | scientific information supplied to the pharmacist and technician by the manufacturer with all prescription drug products; the information must be approved by the FDA |
| prophylactic agent | a drug used to prevent disease |
| psychological dependence | a state in which taking a drug produces a sense of well-being and, consequently, the abrupt termination of the drug may create anxiety withdrawal symptoms |
| radiopharmaceutical | a drug containing radioactive ingredients, often used for diagnostic or therapeutic purposes |
| ribonucleic acid (RNA) | an important component of the genetic code that arranges amino acids into proteins |
| risk evaluation and mitigation strategy (REMS) | a requirement by the FDA that procedures be developed by drug manufacturers to ensure that the benefits of selected highrisk drugs on the market outweigh their risks |
| semisynthetic drug | a drug that contains both natural and synthetic components |
| synthesized drug | a drug created artificially in the laboratory but in imitation of a naturally occurring drug |
| synthetic drug | a drug that has been created from a series of chemical reactions to produce a specific pharmacological effect |
| therapeutic agent | a drug that prevents, cures, diagnoses, or relieves symptoms of a disease |
| therapeutic effect | the desired pharmacological action of a drug on the body |
| United States Pharmacopeia–National Formulary (USP–NF) | a drug reference that contains standards for medicines, dosage forms, drug substances, excipients or inactive substances, medical devices, and dietary supplements |
| vaccine | a substance introduced into the body in order to produce immunity to disease |
| Vaccine Adverse Event Reporting System (VAERS) | a postmarketing surveillance system operated by the FDA and CDC that collects information on adverse events that occur after immunization |
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