Term
|
Definition
| they are very similar to other available drugs and add littl to therpaeutic effectiveness; developed where it is anticipated that a large volume of patients will require that type of drug therapy (ex: proton pump inhibitors) |
|
|
Term
|
Definition
| first drug in a class and it serves to illustrate the properties of that drug class; drugs developed after are compared and contrasted with the prototype |
|
|
Term
|
Definition
| aka nonproprietary name; given by the USAN council, only one generic name |
|
|
Term
|
Definition
| pharmeceutical companies develp a drug product; can have multiple brand names |
|
|
Term
|
Definition
| specific use for a drug for which a hermeceutical company receives approval from the FDA; may have more than one FDA approved indication; unlabeled indications is subject to possible malpractic |
|
|
Term
| prescription/legend drugs |
|
Definition
| agents requiring a prescription written by a qualified licensed professional |
|
|
Term
|
Definition
| drugs that have abuse potential; five schedules based on abuse where I is highest and V is lowest |
|
|
Term
|
Definition
| available without a prescription; some are both OTC and prescription in which case the OTC is a smaller dosage |
|
|
Term
|
Definition
| a drug intended to treat, diagnose or prevent a rare disease (fewer than 200,000 peiple) |
|
|
Term
|
Definition
| only available under a treatment investigational new drug (IND) protocol, not yet approved by the FDA, sometimes are under evaluation for a new use/indication |
|
|
Term
|
Definition
| intended to supplement the diet that contains one or more of the following ingredients: vitamin, mineral, herb or botanical, amino acid, increase total daily intake, concentrate, metabolite extract or combination; cannot be represented as food; claims may not be made about its ability to diagnose, prevent, mitigate treat or cure a disease; may bear structure/function claims without FDA approval |
|
|
Term
| steps involved in drug development |
|
Definition
| preclinical research and development, submission of IND application, clinical research and development, new drug application (NDA) and post marketing surveillance |
|
|
Term
|
Definition
| define the initial parameters of tixicity, tolerated dose range, general pharmacokinetic and pharmacodynamic data; small numbers of normal healthy subjects or patients. |
|
|
Term
|
Definition
| assess therapeutic effectiveness, identify common adverse effects and develop a rational dosing strategy. several hundred subjects with the target disease but few other concomitant diseases. |
|
|
Term
|
Definition
| several thousand patients and are esigned to document effectiveness for specific disease indications and clinical safety |
|
|
Term
| preclinical research and development |
|
Definition
| drug is identified or synthesized, data is collected to gain FDA approval for testing; this phase includes animal testing |
|
|
Term
|
Definition
| application seeking approval to begin human clinical testing with the IND |
|
|
Term
| new drug application (NDA) |
|
Definition
| the data accumulated is compiles and submitted to the FDA for review. if adequate evidence for efficacy and safety is included the drug receives FDA approval |
|
|
Term
| post marketing surveillance |
|
Definition
| FDA regulations require that postmarketing be recorded and reported. involves collection and evaluation of spontaneous adverse event reporting |
|
|
Term
|
Definition
| "lock" in the lock and key nalogy; denotes any cellular macromolecule to which a drug binds to |
|
|
Term
|
Definition
| membrane (surface of cell membranes), enzyme (site of bindin on an enzyme to modulate its function), steroid hormone receptors (intracellular which when bound modulate steroid hormone action) |
|
|
Term
| examples of membrane receptors |
|
Definition
| beta adrenergic and insulin receptor |
|
|
Term
| examples of enzyme recptors |
|
Definition
| inhibition of the trasnpeptidase enzyme, inhibition of ACE |
|
|
Term
| examples of steroid hormone receptors |
|
Definition
| cortisol and thyroid hormone |
|
|
Term
|
Definition
| binds to the receptors and mimic the effects of an endogenous regulatory compound |
|
|
Term
|
Definition
|
|
Term
|
Definition
| blocks effect of endogenous agonist by competing for the agonist receptor binding site |
|
|
Term
|
Definition
| propanolol (non-selective) and metoprolol (selective) |
|
|
Term
| partial agnoist/antagonist |
|
Definition
| both properties; ore selective as an agonist at some receptors sites and antagonists at other receptor sites |
|
|
Term
| ex of partial agonist/antagonist |
|
Definition
| raloxifene and succinylcholine |
|
|
Term
|
Definition
| drugs compete with NT; agent with greater affinity or in larger mass will prevail |
|
|
Term
| ex of drugs that bind reversbly |
|
Definition
| NSAIDS (ibuprofn and naproxen) |
|
|
Term
|
Definition
| generation of new receptors such as anothe renzyme may be required to restore receptor action |
|
|
Term
| ex of drug that binds irreversibly |
|
Definition
|
|
Term
|
Definition
| limited list of drugs which should be the most rational list of drugs that can be prescribed to treat common diseases and disorders encountered in the institution (hospital, HMO, insurance) |
|
|
Term
| pharmacy and therapeutics (P & T) committee |
|
Definition
| selects the formulary drugs |
|
|
