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Pharmacology Chapters 1-7 Content
Terms in this set (36)
therapeutics is concerned with the prevention of disease and treatment of suffering
Define pharmacotherapy (or pharmacotherapeutics)
Pharmacotherapy is the application of drugs for the purpose of treating disease and alleviating human suffering.
what is a drug?
a chemical agent capable of producing biologic responses within the body (the responses may be therapeutic or adverse)
after a drug is administered it is called a __________
what are biologics?
agents naturally produced in animal cells, by microorganisms, or by the body itself. (eg. hormones, vaccines, blood)
___________ involve natural plant extracts, herbs, vitamins, minerals, dietary supplements, and additional techniques outside of the realm of conventional therapeutics.
one useful method of organizing drugs is based on their therapeutic usefullness in treating particular diseases or disorders. this is referred to as ______________
A ___________ classification refers to the way a drug works at the molecular, tissue, or body system level.
what does mechanism of action mean?
how a drug produces its physiological effect in the body.
What is a prototype drug?
the well-understood drug model with which other drugs in its representative class are compared
a drug has only one __________ name which is helpful in predicting a substance's physical and chemical properties
a drug is assigned only one ___________ name by the U.S. adopted name council.
which drug name is always lowercase?
which drug name is always capitalized
a drug's ___________ name is assigned by the company marketing the drug and is sometimes called the proprietary, product, or brand name.
a drug developer is given exclusive rights to name and market a drug for _____ years according to the FDA
what is a combination drug?
a drug that contains more than one active generic ingredient
what is a key to comparing trade-name drugs and their generic equivalents?
measuring the bioavailability
what is bioavailability?
the physiological ability of the drug to reach its target cells and produce its effect.
what factors affect bioavailability?
1. inert ingredients and tablet compression
2. anything that affects absorption of a drug or its distribution to target cells
What does USP-NF stand for and what information does it provide?
U.S. Pharmacopoeia - National Formulary and provides information about all drug products and pharmaceutical ingredients (drug purity, strength, and directions for synthesis and lists of drug recipies)
What does the USPMERP do?
provides opportunities for health care providers to search out and report occurrences related to medication safety.
What does the FDA stand for
Food and Drug Administration
What is CDER
Center for Drug Evaluation and Research: a branch of FDA tha exercises control over whether prescription and OTC drugs may be used for therapy
What is a black box warning?
created by the FDA is the primary alerts for identifying extreme adverse reactions discovered during and after the review process
What is CBER
a branch of the FDA: Center for Biologics Evaluation and Research. Regulates the use of biologics
What is CFSAN
Center for Food Safety and Applied Nutrition: a branch of the FDA that oversees administration of herbal products and dietary supplements.
List the branches of the FDA
List the phases of approval for therapeutic and biologic drugs
1. preclinical investigation
2. clinical investigation
3. review of NDA
4. postmarketing surveillance
the _________ phase of approval for a drug involves etensive laboratory research and testing on cells.
the ________ phase of drug approval is the longest part of the approval process
(3-10 yr) and tests are performed on volunteers and large groups of selected participants
clinical (2nd phase)
How long does the preclinical phase last?
when does a 30 day safety review occur?
in between the first and the second phases
What is the difference between an NDA and an IND?
An NDA is a New Drug Application and must be submitted before a drug is allowed to proceed to the 3rd phase of drug approval.
An IND is an Investigational New Drug application and may be submitted for phase I clinical trials when it is determined that there are significant therapeutic benefits and the product is reasonably safe.
Describe the 3rd phase of drug approval
New Drug Application Review phase: during this phase, the drug's trade name is finalized. range: 2 months - 7 years.
What is the final phase of drug approval process and what is its purpose?
Postmarketing surveillance: goal - to survey for harmful drug effects in a larger population.
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