NAPSR/CNPR Exam|Complete Questions with 100% Correct Answers
approvable letter
letters sent by the FDA to the applicant indicating whether the new drug application meets necessary
requirements.
asymptomatic
without sings or symptoms of disease.
blinded or masked study
a study in which participants do not know whether they are in the experimental or control group in a
research study.
control or control group
the standard by which experimental observations are evaluated.
double-blind or double masked study
one in which neither the participants nor the study staff know which participants are receiving the
experimental treatment and which ones are getting either a standard treatment or a placebo.
edema
swelling.
fast-track drugs
fast-track approval is provided for drugs that meet medical needs for patients with serious or life-
threatening conditions.
indication
in terms of drugs approval, the exact cause or purpose for which the FDA has approved that a drug
can be prescribed
institutional review board (IRB)
committee of physicians, statisticians, community advocated, and others which ensure that a clinical
trial is ethical and that the rights of the study participants are protected. All clinical trials must be
approved by an IRB before they begin.
off label
usage of a medication for purposes other than the specific ones appearing in the labeling.
placebo
inactive pill, liquid, or powder that has no treatment value.
placebo effect
the effect produced by a placebo due to the expectations of the patient.
,study protocol
the general design and operating features of a trial. it is distinguished from the study manual of
operations by its generality and absence of specific details needed for day-to-day execution of the
trial.
toxicity
the extent, quality, or degree to which a substance is a poisonous or harmful to the body.
treatment group
a group of patients assigned to receive a specified treatment.
anatomy
study of the basic structures of the body.
physiology
study of how those body structures function.
clinical pharmacology
study of the effects and movement of drugs in the human body.
how many prescriptions are dispensed in the united states each year?
3 billion.
pharmacodynamics
study of the biochemical and physiological effects of drugs and their mechanisms of action.
pharmacokinetics
study of how a drug is processed by the body, with emphasis on the time required for absorption,
duration of action, distribution, and method of excretion. the study of how the body affects drugs.
drug distribution and elimination
drug delivery systems, route of administration, modes of excretion.
drug
a substance other than food that changes the structure or function of the body or mind.
what are the three names of drugs?
chemical name, generic name, and one or more trade names.
chemical name
describes the atomic or molecular structure of the drug.
generic name
legal noncommercial name for a drug.
,trade name
chosen by the pharmaceutical company that manufactures or distributes the drug.
pharmakon
medicine
logos
study
pharmacology
study of medicine
aminoglycosides
class of antibiotics that are useful in the treatment of many infectious diseases.
ADME testing
measures the rate at which the body absorbs the drug, distributes it to the organs necessary to
produce the desired effect, metabolizes it into waste material and then excretes it from the body.
absorption
how the drug passes from its site of administration into the bloodstream.
distribution
how the drug is dispersed among the organs of the body after it is absorbed into the bloodstream,
and how much reaches the target organs.
metabolism
how the active part of the drug is metabolized into a more water-soluble compound that can be
readily excreted by the kidneys.
excretion
how the drug is eliminated from the body.
placebos
substances that appear to be drugs but are not.
margin of safety
the difference between the usual effective dose and the dose that induces severe or life threatening
side effects.
what are the five rights of drug administration?
right patient, right medication, right dose, right route of administration, and right time of delivery.
, inhalation
drugs taken through the lungs by inhaling in aerosol form.
injection routes
administration by injection (parenteral administration) includes the subcutaneous, intramuscular,
intravenous, and intrathecal routes.
intramuscular injection
drugs given by injection into muscle tissue such as: buttocks, upper arm, or thighs.
intrathecal injection
needle is inserted between two vertebrae in the lower spine and into the space around the spinal
cord.
intravenous or IV
refers to drugs injected directly into the veins.
subcutaneous injection
needle is inserted into fatty tissue just beneath the skin.
oral administration (PO)
refers to tablets, capsules, and liquids taken by the mouth.
rectal route
drugs that are administered orally can also be administered rectally as a suppository.
vaginal route
drugs may be administered vaginally to women as a solution, tablet, cream, gel, or suppository.
sublingual route
drugs taken under the tongue and absorbed directly and almost immediately into the blood stream
through the mucous membranes of the mouth.
ocular route
drugs used to treat eye disorders.
nasal route
drug is to be breathed in and absorbed through the thin mucous membrane that lines the nasal
passages, must be transformed into tiny droplets in air (atomized).
topical or cutaneous
drugs administered through the skin for local effects on that area of the skin.
approvable letter
letters sent by the FDA to the applicant indicating whether the new drug application meets necessary
requirements.
asymptomatic
without sings or symptoms of disease.
blinded or masked study
a study in which participants do not know whether they are in the experimental or control group in a
research study.
control or control group
the standard by which experimental observations are evaluated.
double-blind or double masked study
one in which neither the participants nor the study staff know which participants are receiving the
experimental treatment and which ones are getting either a standard treatment or a placebo.
edema
swelling.
fast-track drugs
fast-track approval is provided for drugs that meet medical needs for patients with serious or life-
threatening conditions.
indication
in terms of drugs approval, the exact cause or purpose for which the FDA has approved that a drug
can be prescribed
institutional review board (IRB)
committee of physicians, statisticians, community advocated, and others which ensure that a clinical
trial is ethical and that the rights of the study participants are protected. All clinical trials must be
approved by an IRB before they begin.
off label
usage of a medication for purposes other than the specific ones appearing in the labeling.
placebo
inactive pill, liquid, or powder that has no treatment value.
placebo effect
the effect produced by a placebo due to the expectations of the patient.
,study protocol
the general design and operating features of a trial. it is distinguished from the study manual of
operations by its generality and absence of specific details needed for day-to-day execution of the
trial.
toxicity
the extent, quality, or degree to which a substance is a poisonous or harmful to the body.
treatment group
a group of patients assigned to receive a specified treatment.
anatomy
study of the basic structures of the body.
physiology
study of how those body structures function.
clinical pharmacology
study of the effects and movement of drugs in the human body.
how many prescriptions are dispensed in the united states each year?
3 billion.
pharmacodynamics
study of the biochemical and physiological effects of drugs and their mechanisms of action.
pharmacokinetics
study of how a drug is processed by the body, with emphasis on the time required for absorption,
duration of action, distribution, and method of excretion. the study of how the body affects drugs.
drug distribution and elimination
drug delivery systems, route of administration, modes of excretion.
drug
a substance other than food that changes the structure or function of the body or mind.
what are the three names of drugs?
chemical name, generic name, and one or more trade names.
chemical name
describes the atomic or molecular structure of the drug.
generic name
legal noncommercial name for a drug.
,trade name
chosen by the pharmaceutical company that manufactures or distributes the drug.
pharmakon
medicine
logos
study
pharmacology
study of medicine
aminoglycosides
class of antibiotics that are useful in the treatment of many infectious diseases.
ADME testing
measures the rate at which the body absorbs the drug, distributes it to the organs necessary to
produce the desired effect, metabolizes it into waste material and then excretes it from the body.
absorption
how the drug passes from its site of administration into the bloodstream.
distribution
how the drug is dispersed among the organs of the body after it is absorbed into the bloodstream,
and how much reaches the target organs.
metabolism
how the active part of the drug is metabolized into a more water-soluble compound that can be
readily excreted by the kidneys.
excretion
how the drug is eliminated from the body.
placebos
substances that appear to be drugs but are not.
margin of safety
the difference between the usual effective dose and the dose that induces severe or life threatening
side effects.
what are the five rights of drug administration?
right patient, right medication, right dose, right route of administration, and right time of delivery.
, inhalation
drugs taken through the lungs by inhaling in aerosol form.
injection routes
administration by injection (parenteral administration) includes the subcutaneous, intramuscular,
intravenous, and intrathecal routes.
intramuscular injection
drugs given by injection into muscle tissue such as: buttocks, upper arm, or thighs.
intrathecal injection
needle is inserted between two vertebrae in the lower spine and into the space around the spinal
cord.
intravenous or IV
refers to drugs injected directly into the veins.
subcutaneous injection
needle is inserted into fatty tissue just beneath the skin.
oral administration (PO)
refers to tablets, capsules, and liquids taken by the mouth.
rectal route
drugs that are administered orally can also be administered rectally as a suppository.
vaginal route
drugs may be administered vaginally to women as a solution, tablet, cream, gel, or suppository.
sublingual route
drugs taken under the tongue and absorbed directly and almost immediately into the blood stream
through the mucous membranes of the mouth.
ocular route
drugs used to treat eye disorders.
nasal route
drug is to be breathed in and absorbed through the thin mucous membrane that lines the nasal
passages, must be transformed into tiny droplets in air (atomized).
topical or cutaneous
drugs administered through the skin for local effects on that area of the skin.
