Term
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Definition
drugs that are similar to other available drugs and add little, if anything, to therapeutic
effectiveness
ex: omeprazole - proton pump inhibitor |
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Term
| nonproprietary or generic name |
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Definition
| name for a drug made by the United States Adopted Names (USAN) Council |
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Term
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Definition
what pharmaceutical companies market the drug under
ex: lisinopril/Zestril/Prinivil |
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Term
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Definition
the specific use for a drug for which a pharmaceutical company
receives approval from the FDA |
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Term
| Prescription or legend drugs: |
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Definition
| Agents requiring a prescription written by a qualified licensed professional. |
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Term
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Definition
Drugs that have abuse potential. They are divided into
five schedules based on their potential for abuse and physical and psychological
dependence |
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Term
Schedule I has the highest abuse potential, while schedule V has
the lowest abuse potential. |
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Definition
| what Schedule of drug has the highest abuse potential? |
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Term
Drug Enforcement Agency with in the Department
of Justice |
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Definition
| Enforcement of regulations on controlled substances is under the jurisdiction of who? |
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Term
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Definition
| products are available without a prescription |
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Term
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Definition
A drug intended to treat, diagnose, or prevent a rare disease
(applies to biologic products as well). |
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Term
A rare disease either affects fewer than
200,000 people in the US or for diseases affecting greater than 200,000 people for which there is no reasonable expectation that the cost of developing and making available in the US a drug for such a disease or condition will be
recovered from sales in the US. |
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Definition
| For an Orphan drug, what is the limit for a disease to be considered "rare"? |
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Term
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Definition
drug products only available under a treatment
Investigational New Drug (IND) protocol and not yet approved by the FDA for
general distribution and use |
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Term
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Definition
a product that is intended to supplement the
diet that contains one or more of the following ingredients: vitamin, mineral, herb
or botanical, amino acid, dietary substance for use by man to supplement the diet
by increasing the total daily intake, or a concentrate, metabolite, constituent,
extract or combinations of these ingredients. |
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Term
A DS cannot be represented as a food. Claims may not be made about
the use of a DS to diagnose, prevent, mitigate, treat, or cure a specific
disease. For example a product may not carry the claim “cures cancer” or
“treats arthritis”. DS labeling may bear health claims authorized by the
FDA such as the claim linking folic acid and reduced risk of neural tube
birth defects.
o A DS label may bear structure/function claims without prior FDA approval,
such as effects on “structure or function” of the body or the “well-being”
achieved by consuming the DS. For example “maintains healthy
circulatory system”, “calcium builds strong bones”, or “antioxidants
maintain cell integrity”. |
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Definition
| What can a DS label claim and not claim? |
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Term
1) Preclinical research and development
2) Submission of IND application to the FDA
3) Clinical research and development (phases 1,2,3)
4) New Drug application (NDA)
5) Post marketing surveillance |
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Definition
| List the phases of drug development in order |
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Term
| Preclinical research and development |
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Definition
During this period the drug is identified or synthesized and enough data is collected to gain FDA approval for testing in humans. This phase includes animal testing to evaluate pharmacological and
toxicological effects. FDA regulations at this stage are focused on assurance of good laboratory practices. |
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Term
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Definition
This is an application seeking
approval to begin human clinical testing with the investigational new drug |
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Term
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Definition
these studies are intended to define the initial
parameters of toxicity, tolerated dose range, general pharmacokinetic and
pharmacodynamic data. They may include small numbers (10 to 80) of
normal healthy subjects or patients. The FDA focus for these trials is to
ensure that subjects are not exposed to unreasonable risks. |
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Term
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Definition
these studies are designed to assess therapeutic
effectiveness, identify common adverse effects, and develop a rational
dosing strategy. They typically include several hundred subjects with the
Pharmacology Concepts 5
target disease but few other concomitant diseases. The FDA review
focuses on the scientific merit of the study |
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Term
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Definition
these studies involve up to several thousand patients
and are designed to document effectiveness for specific disease
indications and clinical safety. The FDA review focus here is to ensure the
research content will likely lead to drug approval |
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Term
| New Drug application (NDA): |
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Definition
The data accumulated under the IND is compiled
into a ______ and submitted to the FDA for review. If adequate evidence of drug
efficacy and safety is included the drug receives FDA approval for specified
indications. |
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Term
| Post marketing surveillance |
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Definition
FDA regulations require that postmarketing
adverse events be recorded and reported. This involves collection and evaluation
of spontaneous adverse event reporting and may involve phase 4 studies
designed to evaluate drug effectiveness and safety in the clinical setting. |
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Term
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Definition
used to denote any cellular
macromolecule to which a drug binds to initiate its effects |
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Term
1) membrane
2)enzyme
3)intracellular/steroid |
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Definition
| list the three types of receptors |
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Term
membrane receptors:
beta 1: heart- rate/contractility
beta 2: lungs- bronchodilation,
skeletal muscle- tremors
beta 3: |
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Definition
| list the beta adrenergic receptors and their location. what kind of receptors are they? |
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Term
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Definition
| what type of receptors is the insulin receptors? |
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Term
| enzyme receptors (the transpeptidase enzyme for cross linking in bacterial cell walls) |
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Definition
| what type of receptors to penicillins and cephalosporins bind to? |
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Term
| Enzyme receptors, they are ACE inhbitors that cause vascular smooth muscle vasodilation to lower blood pressure |
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Definition
| what type of receptorsdo lisinopril and captopril bind to? |
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Term
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Definition
| what type of receptors do prednisone use? |
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Term
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Definition
| what type of receptors does levothyroxine use? |
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Term
| Pharmacodynamics or pharmacology |
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Definition
study of the biochemical and
physiological effects of drugs and their mechanism of action. |
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Term
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Definition
an agent, including endogenous substances that bind to
physiological receptors and mimic the effects of an endogenous regulatory compound |
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Term
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Definition
| blocks effect of endogenous agonist by competing for the agonist receptor binding site. |
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Term
metoprolol is selective for beta 1 so it affects the heart and not the lungs as much
propanolol non-selectively binds and blocks beta 1 and 2 (slows hr and prevents bronchodilation) |
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Definition
| metroprolol and propanolol are both beta antagonists, how do they differ? |
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Term
| partial agonist/antagonist |
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Definition
compounds with both agonist and antagonist properties meaning they are relatively more selective as an agonist at some receptor sites and antagonists at other receptor sites
or
it acts an an agonist with an initial binding to ther receptor, but stays bound to the receptor to block the endogenous neurotransmitter from stimulating the receptor |
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Term
1) raloxifene a SERM for osteoporosis agonist on bone, but neutral antagonist on estrogen receptors in the endometrium and breast
2) succinylcholine, binds nicotinic receptors causing initial depolarization(agonist) but then remains bound to the receptor, delays repolarization and blocks ACh |
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Definition
| give 2 examples of partial agonist/antagonists |
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Term
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Definition
Drugs usually bind _______ at receptors: drugs then _______ with endogenous neurotransmitters or other agents for the receptor or enzyme; the agent
with greater affinity or in larger mass will generally prevail. |
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Term
| NSAIDS(except aspirin) bind reversibly to the platelet COX enzyme, so the effect lasts as long as the drug is present at the site of action |
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Definition
| give an example of a drug that binds reversibly |
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Term
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Definition
| Some drugs bind ________ at receptors: when this occurs generation of new receptors, such as another enzyme, may be required to restore receptor action. |
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Term
| the acetyl part of aspirin binds irreversibly to platelt COX, so the effect lasts the lifetime of the platelet |
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Definition
| give an example of a drug that binds irreversibly |
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Term
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Definition
| a 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 |
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