NAPSR/CNPR Exam - 14th Edition
The FDA regulates the introduction of new drugs and enforces U.S. drug laws. -
correct answer True
Pharma companies must submit extensive data to the FDA demonstrating the
safety and effectiveness of new drugs before receiving approval for sale. - correct
answer True
Average review time for a new drug - correct answer 18 months
Sales Team - correct answer Pg 7
The "engine of innovation," focused on discovering or inventing promising new
product. - correct answer Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the
business. - correct answer Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - correct
answer True
3,070 new meds are in development for cancer. - correct answer True
Define Off-label - correct answer Usage of a medication for purposes other than
the specific ones appearing on the label
Toxicity - correct answer The extent, quality, or degree to which a substance is
poisonous or harmful to the body
Institutional review Board (IRB) - correct answer A committee of physicians,
staticians, 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.
Placebo - correct answer Inactive pill, liquid, or powder that has no treatment
value aka sugar pill
Edema - correct answer Swelling
Asymptomatic - correct answer Without signs or symptoms
Clinical Pharmacology - correct answer The study of the effects and movement of
drugs in the human body
,NAPSR/CNPR Exam - 14th Edition
Anatomy - correct answer The study of basic structures of the body
Physiology - correct answer The study of how those body structures function
Basic clinical pharmacology involves 3 main concepts - correct answer
Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics - correct answer Study of the biochemical and physiological
effects of drugs and their mechanisms of action i.e. the study of what a drug does
to the body. It describes the therapeutic effects of drugs (pain relief, blood
pressure reduction, their side effects and their sites of action.
Pharmacokinetics - correct answer 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 & elimination - correct answer Drug delivery systems, route of
administration , modes of excretion.
Plasma - correct answer The liquid portion of the blood that carries proteins and
other substances
Organs - correct answer Specialized cells and tissues grouped together to
perform specific body function for a common purpose. (Kidney, heart, intestines,
and skin)
Nucleus - correct answer Brain of the cell that regulates all activities.
Proteins - correct answer A nutrient made up of of chains of amino acids
Fats - correct answer A nutrient stored in special body tissues as a great source
of reserve energy
Carbohydrates - correct answer A nutrient that is the body's immediate source of
energy. It's broken down to glucose and used for immediate metabolic reactions.
Vitamins - correct answer A nutrient substance necessary for growth,
development, and normal regulation of metabolic processes. Must be taken from
outside the body.
Minerals - correct answer A nutrient necessary for bodily purposes such as the
balance of body fluid
, NAPSR/CNPR Exam - 14th Edition
Water is NOT a nutrient - correct answer True
Body's Major Systems - correct answer Cardiovascular, Respiratory, nervous,
musculoskeletal, reproductive, immune
Absorption - correct answer How the drug passes from its side of administration
into the bloodstream
Distribution - correct answer How the drug is dispersed among the organs after
absorption into the blood
Metabolism - correct answer How the active part of a drug is metabolized into a
more water-soluble compound that can be readily excreted by the kidneys
Excretion - correct answer How the drug is eliminated from the body. Usually
drugs are eliminated via urine. They can also be excreted through the lungs, skin,
or breast milk.
It takes about 10 years for a drug to hit the market - correct answer True
Routes of drug administration - correct answer Pg 36-38
Rights of drug administration - correct answer pg 32
Bioavailability - correct answer how quickly and how much of a drug reaches its
intended target site of action
Bioequivalent - correct answer when they contain the same active ingredients
and proceed virtually the same blood levels over time.
Therapeutic equivalence - correct answer Production of the same medicinal
effect
Drug elimination and Excretion - correct answer pg 42
Drug Forms - correct answer Pg 43-47
Patent last 20 years - correct answer True
Inactive ingredients - correct answer Added to provide bulk, strength, aid
dissolving, color, taste, etc. IAs do not affect the body
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