NURS 6015 LATEST QUESTIONS AND ANSWERS.
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brand name
name given to a drug by the pharmaceutical company that develop it also called a trade
name or proprietary name
generic drugs
the original designation that a drug is given when the drug company that developed it
applies for the approval process
OTC drugs
drugs that are available without a prescription for self treatment of a variety of
complaints deemed to be safe when used as directly often formerly only available by
prescription
phase 1 study
a pilot study of a potential drug using a small number of selected usually healthy human
volunteers
phase ll study
a clinical study of a proposed drug by selected physicians using actual patients who
have the disorder the drug is designed to treat patients must provide informed consent
phase lll study
use of the proposed drug on a wide scale in the clinical setting with patients who have
the disease the drug is thought to treat
phase iv study
continous evaluation of a drug after it has been released for marketing
Food and Drug administration
after a chemical that might have a therapeutic value is identified it must undergo a
series of scientific test to evaluate its actual therapeutic and toxic effects this process is
tightly controlled by the FDA
FDA
an agency of the U.S. department of health and human services that regulates the
development and sale of drugs
before receiving the final FDA approval to be marketed to the public drugs must
pass through several stages of development these include
preclinical tries and phase l, ll, and lll studies
preclinical trials
chemicals that may have therapeutic value are tested on laboratory animals for two
main purposes
1. determine whether they have the presumed effects in living tissue
2. evaluate any adverse effects
at the end of the preclinical trials some chemicals are discarded for the following
reasons
-chemical lacks therapeutic activity when used with living animals
-chemical is too toxic
, -chemical is highly teratogenic (cause adverse effects to a fetus)
-safety margins are so small that the chemical would not be useful in the clinical setting
some chemicals are found to have therapeutic effects and reasonably safety
margins this means that?
the chemicals are therapeutic at doses that are reasonably different from doses that
cause toxic effects
phase 1 study uses ___ to test the drugs
human volunteers
phase 1 study are more tightly controlled than preclinical trials and are performed
by
specially trained clinical investigator
phase 1 study volunteers are fully informed of possible risks and may be paid for
their participation usually the volunteers are?
healthy young men and often woman, woman of childbearing potential ares sometimes
not good candidates
at the end of phase 1 studies many chemicals are dropped from the process for
the following reasons
- unacceptable adverse effects
-highly teratogenic
-too toxic
-lack evidence of potential therapeutic effects in humans
some chemicals move to the next stage of testing despite undesirable effects for
example the antihypertensive drug minoxidil was found to effectively treat
malignant hypertension but it caused unusual hair growth on the palm and other
body areas however because it was much more effective for treating
malignant hypertension at the time of its development than any other drug and because
the undesired effects were not dangerous sit proceeded to phase 11 studies now its hair
growing effect has been channeled for therapeutic use into various topical hair growth
preparations such as rogaine
phase ll studies allow clinical investigators to try out the drug in?
patients who have the disease that the drug is designed to treat
usually phase ll studies are performed at
various sites across the country in hospitals, clinic, and doctors' offices
at the end of phase ll studies a drug may be removed from further investigation
for the following reasons
-less effective than anticipated
-too toxic when used with patients
-unacceptable adverse effects
-has a low benefit to risk ratio meaning that the therapeutic benefit it provides does not
outweigh the risk that the adverse effects cause
-no more effective than other drugs already not eh market
phase ll study involves use of the drug in a?
vast clinical market
phase lll study prescribers are informed of all the known reactions to the drug ad
precautions required for its safe use prescribers then
Buy Quality Materials!
brand name
name given to a drug by the pharmaceutical company that develop it also called a trade
name or proprietary name
generic drugs
the original designation that a drug is given when the drug company that developed it
applies for the approval process
OTC drugs
drugs that are available without a prescription for self treatment of a variety of
complaints deemed to be safe when used as directly often formerly only available by
prescription
phase 1 study
a pilot study of a potential drug using a small number of selected usually healthy human
volunteers
phase ll study
a clinical study of a proposed drug by selected physicians using actual patients who
have the disorder the drug is designed to treat patients must provide informed consent
phase lll study
use of the proposed drug on a wide scale in the clinical setting with patients who have
the disease the drug is thought to treat
phase iv study
continous evaluation of a drug after it has been released for marketing
Food and Drug administration
after a chemical that might have a therapeutic value is identified it must undergo a
series of scientific test to evaluate its actual therapeutic and toxic effects this process is
tightly controlled by the FDA
FDA
an agency of the U.S. department of health and human services that regulates the
development and sale of drugs
before receiving the final FDA approval to be marketed to the public drugs must
pass through several stages of development these include
preclinical tries and phase l, ll, and lll studies
preclinical trials
chemicals that may have therapeutic value are tested on laboratory animals for two
main purposes
1. determine whether they have the presumed effects in living tissue
2. evaluate any adverse effects
at the end of the preclinical trials some chemicals are discarded for the following
reasons
-chemical lacks therapeutic activity when used with living animals
-chemical is too toxic
, -chemical is highly teratogenic (cause adverse effects to a fetus)
-safety margins are so small that the chemical would not be useful in the clinical setting
some chemicals are found to have therapeutic effects and reasonably safety
margins this means that?
the chemicals are therapeutic at doses that are reasonably different from doses that
cause toxic effects
phase 1 study uses ___ to test the drugs
human volunteers
phase 1 study are more tightly controlled than preclinical trials and are performed
by
specially trained clinical investigator
phase 1 study volunteers are fully informed of possible risks and may be paid for
their participation usually the volunteers are?
healthy young men and often woman, woman of childbearing potential ares sometimes
not good candidates
at the end of phase 1 studies many chemicals are dropped from the process for
the following reasons
- unacceptable adverse effects
-highly teratogenic
-too toxic
-lack evidence of potential therapeutic effects in humans
some chemicals move to the next stage of testing despite undesirable effects for
example the antihypertensive drug minoxidil was found to effectively treat
malignant hypertension but it caused unusual hair growth on the palm and other
body areas however because it was much more effective for treating
malignant hypertension at the time of its development than any other drug and because
the undesired effects were not dangerous sit proceeded to phase 11 studies now its hair
growing effect has been channeled for therapeutic use into various topical hair growth
preparations such as rogaine
phase ll studies allow clinical investigators to try out the drug in?
patients who have the disease that the drug is designed to treat
usually phase ll studies are performed at
various sites across the country in hospitals, clinic, and doctors' offices
at the end of phase ll studies a drug may be removed from further investigation
for the following reasons
-less effective than anticipated
-too toxic when used with patients
-unacceptable adverse effects
-has a low benefit to risk ratio meaning that the therapeutic benefit it provides does not
outweigh the risk that the adverse effects cause
-no more effective than other drugs already not eh market
phase ll study involves use of the drug in a?
vast clinical market
phase lll study prescribers are informed of all the known reactions to the drug ad
precautions required for its safe use prescribers then
