NAPSR/CNPR Exam Study Guide Question And Answer
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
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
