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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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