NURS 6015 EXAM 1 PRACTICE QUESTIONS
(CHAPTERS 1-11) ANSWERED CORRECT |
2026 UPDATE | SCORED A+
FDA - ANSWERS-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 -
ANSWERS-preclinical tries and phase l, ll, and lll studies
preclinical trials - ANSWERS-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 - ANSWERS--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? - ANSWERS-the chemicals are therapeutic at
doses that are reasonably different from doses that cause toxic effects
phase 1 study uses ___ to test the drugs - ANSWERS-human volunteers
,phase 1 study are more tightly controlled than preclinical trials and are
performed by - ANSWERS-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? - ANSWERS-healthy young
men and often woman, woman of childbearing potential ares sometimes not
good candidates
adverse effects - ANSWERS-drug effects, sometimes called side effects that
are not the desired therapeutic effects may be unpleasant or even dangerous
brand name - ANSWERS-name given to a drug by the pharmaceutical
company that develop it also called a trade name or proprietary name
generic drugs - ANSWERS-the original designation that a drug is given when
the drug company that developed it applies for the approval process
OTC drugs - ANSWERS-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 - ANSWERS-a pilot study of a potential drug using a small
number of selected usually healthy human volunteers
phase ll study - ANSWERS-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 - ANSWERS-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 - ANSWERS-continous evaluation of a drug after it has been
released for marketing
Food and Drug administration - ANSWERS-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
at the end of phase 1 studies many chemicals are dropped from the process
for the following reasons - ANSWERS-- 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 - ANSWERS-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? -
ANSWERS-patients who have the disease that the drug is designed to treat
usually phase ll studies are performed at - ANSWERS-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 - ANSWERS--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? - ANSWERS-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 - ANSWERS-
observe patients closely monitoring them for adverse effects they often ask
patients to keep journals and record any symptoms prescribers then evaluate
the reported effects to determine whether they are caused by the disease or
by the drug this information is collected by the drug company and is shared
with the FDA
drugs that finish phase lll studies are evaluated by the FDA which relies on
committees of experts familiar with the speciality area in which the drug will
be used - ANSWERS-only those drugs that receive FDA committee approval
may be marketed
an approved drug is given a __ __ by the pharmaceutical company that
developed it. the __ __ of a drug is the original designation that the drug was
given when the drug company applied for the approval process. -
ANSWERS-brand name, generic name
a drug can be ___ if in phase lll studies it shows great promise and no other
drug is available that gives those effects - ANSWERS-fast tracked
(CHAPTERS 1-11) ANSWERED CORRECT |
2026 UPDATE | SCORED A+
FDA - ANSWERS-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 -
ANSWERS-preclinical tries and phase l, ll, and lll studies
preclinical trials - ANSWERS-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 - ANSWERS--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? - ANSWERS-the chemicals are therapeutic at
doses that are reasonably different from doses that cause toxic effects
phase 1 study uses ___ to test the drugs - ANSWERS-human volunteers
,phase 1 study are more tightly controlled than preclinical trials and are
performed by - ANSWERS-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? - ANSWERS-healthy young
men and often woman, woman of childbearing potential ares sometimes not
good candidates
adverse effects - ANSWERS-drug effects, sometimes called side effects that
are not the desired therapeutic effects may be unpleasant or even dangerous
brand name - ANSWERS-name given to a drug by the pharmaceutical
company that develop it also called a trade name or proprietary name
generic drugs - ANSWERS-the original designation that a drug is given when
the drug company that developed it applies for the approval process
OTC drugs - ANSWERS-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 - ANSWERS-a pilot study of a potential drug using a small
number of selected usually healthy human volunteers
phase ll study - ANSWERS-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 - ANSWERS-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 - ANSWERS-continous evaluation of a drug after it has been
released for marketing
Food and Drug administration - ANSWERS-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
at the end of phase 1 studies many chemicals are dropped from the process
for the following reasons - ANSWERS-- 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 - ANSWERS-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? -
ANSWERS-patients who have the disease that the drug is designed to treat
usually phase ll studies are performed at - ANSWERS-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 - ANSWERS--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? - ANSWERS-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 - ANSWERS-
observe patients closely monitoring them for adverse effects they often ask
patients to keep journals and record any symptoms prescribers then evaluate
the reported effects to determine whether they are caused by the disease or
by the drug this information is collected by the drug company and is shared
with the FDA
drugs that finish phase lll studies are evaluated by the FDA which relies on
committees of experts familiar with the speciality area in which the drug will
be used - ANSWERS-only those drugs that receive FDA committee approval
may be marketed
an approved drug is given a __ __ by the pharmaceutical company that
developed it. the __ __ of a drug is the original designation that the drug was
given when the drug company applied for the approval process. -
ANSWERS-brand name, generic name
a drug can be ___ if in phase lll studies it shows great promise and no other
drug is available that gives those effects - ANSWERS-fast tracked
