NAPSR/CNPR Exam Questions with
Complete Solutions
Pharma companies must submit extensive data to the FDA demonstrating the safety
and effectiveness of new drugs before receiving approval for sale. - Answer-True
Average review time for a new drug - Answer-18 months
Sales Team - Answer-Pg 7
The "engine of innovation," focused on discovering or inventing promising new product.
- Answer-Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the
business. - Answer-Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - Answer-True
3,070 new meds are in development for cancer. - Answer-True
Define Off-label - Answer-Usage of a medication for purposes other than the specific
ones appearing on the label
Toxicity - Answer-The extent, quality, or degree to which a substance is poisonous or
harmful to the body
Institutional review Board (IRB) - 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 - Answer-Inactive pill, liquid, or powder that has no treatment value aka sugar
pill
Edema - Answer-Swelling
Asymptomatic - Answer-Without signs or symptoms
Clinical Pharmacology - Answer-The study of the effects and movement of drugs in the
human body
Anatomy - Answer-The study of basic structures of the body
Physiology - Answer-The study of how those body structures function
,Basic clinical pharmacology involves 3 main concepts - Answer-Pharmacodynamics,
Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics - 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 - 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 - Answer-Drug delivery systems, route of administration ,
modes of excretion.
Plasma - Answer-The liquid portion of the blood that carries proteins and other
substances
Organs - Answer-Specialized cells and tissues grouped together to perform specific
body function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus - Answer-Brain of the cell that regulates all activities.
Proteins - Answer-A nutrient made up of of chains of amino acids
Fats - Answer-A nutrient stored in special body tissues as a great source of reserve
energy
Carbohydrates - 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 - Answer-A nutrient substance necessary for growth, development, and normal
regulation of metabolic processes. Must be taken from outside the body.
Minerals - Answer-A nutrient necessary for bodily purposes such as the balance of body
fluid
Water is NOT a nutrient - Answer-True
Body's Major Systems - Answer-Cardiovascular, Respiratory, nervous, musculoskeletal,
reproductive, immune
Absorption - Answer-How the drug passes from its side of administration into the
bloodstream
, Distribution - Answer-How the drug is dispersed among the organs after absorption into
the blood
Metabolism - 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 - 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 - Answer-True
Routes of drug administration - Answer-Pg 26-29
Seven rights of drug administration - Answer-pg 30
Bioavailability - Answer-how quickly and how much of a drug reaches its intended target
site of action
Bioequivalent - Answer-when they contain the same active ingredients and proceed
virtually the same blood levels over time.
Therapeutic equivalence - Answer-Production of the same medicinal effect
Drug elimination and Excretion - Answer-pg 34
Drug Forms - Answer-Pg 35-38
Patent last 20 years - Answer-True
Inactive ingredients - Answer-Added to provide bulk, strength, aid dissolving, color,
taste, etc. IAs do not affect the body
Pharmaceutical Ingredients - Answer-Pg 54
BID - Answer-twice a day
Cmax - Answer-Peak plasma concentration on a measuring curve
Half-life - Answer-Period of time it takes for a specific amount of drug in the body to be
reduced, through the excretion or elimination process, to exactly one-half that original
amount
PRN - Answer-As needed
QD - Answer-Once a day
Complete Solutions
Pharma companies must submit extensive data to the FDA demonstrating the safety
and effectiveness of new drugs before receiving approval for sale. - Answer-True
Average review time for a new drug - Answer-18 months
Sales Team - Answer-Pg 7
The "engine of innovation," focused on discovering or inventing promising new product.
- Answer-Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the
business. - Answer-Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - Answer-True
3,070 new meds are in development for cancer. - Answer-True
Define Off-label - Answer-Usage of a medication for purposes other than the specific
ones appearing on the label
Toxicity - Answer-The extent, quality, or degree to which a substance is poisonous or
harmful to the body
Institutional review Board (IRB) - 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 - Answer-Inactive pill, liquid, or powder that has no treatment value aka sugar
pill
Edema - Answer-Swelling
Asymptomatic - Answer-Without signs or symptoms
Clinical Pharmacology - Answer-The study of the effects and movement of drugs in the
human body
Anatomy - Answer-The study of basic structures of the body
Physiology - Answer-The study of how those body structures function
,Basic clinical pharmacology involves 3 main concepts - Answer-Pharmacodynamics,
Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics - 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 - 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 - Answer-Drug delivery systems, route of administration ,
modes of excretion.
Plasma - Answer-The liquid portion of the blood that carries proteins and other
substances
Organs - Answer-Specialized cells and tissues grouped together to perform specific
body function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus - Answer-Brain of the cell that regulates all activities.
Proteins - Answer-A nutrient made up of of chains of amino acids
Fats - Answer-A nutrient stored in special body tissues as a great source of reserve
energy
Carbohydrates - 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 - Answer-A nutrient substance necessary for growth, development, and normal
regulation of metabolic processes. Must be taken from outside the body.
Minerals - Answer-A nutrient necessary for bodily purposes such as the balance of body
fluid
Water is NOT a nutrient - Answer-True
Body's Major Systems - Answer-Cardiovascular, Respiratory, nervous, musculoskeletal,
reproductive, immune
Absorption - Answer-How the drug passes from its side of administration into the
bloodstream
, Distribution - Answer-How the drug is dispersed among the organs after absorption into
the blood
Metabolism - 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 - 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 - Answer-True
Routes of drug administration - Answer-Pg 26-29
Seven rights of drug administration - Answer-pg 30
Bioavailability - Answer-how quickly and how much of a drug reaches its intended target
site of action
Bioequivalent - Answer-when they contain the same active ingredients and proceed
virtually the same blood levels over time.
Therapeutic equivalence - Answer-Production of the same medicinal effect
Drug elimination and Excretion - Answer-pg 34
Drug Forms - Answer-Pg 35-38
Patent last 20 years - Answer-True
Inactive ingredients - Answer-Added to provide bulk, strength, aid dissolving, color,
taste, etc. IAs do not affect the body
Pharmaceutical Ingredients - Answer-Pg 54
BID - Answer-twice a day
Cmax - Answer-Peak plasma concentration on a measuring curve
Half-life - Answer-Period of time it takes for a specific amount of drug in the body to be
reduced, through the excretion or elimination process, to exactly one-half that original
amount
PRN - Answer-As needed
QD - Answer-Once a day
