NAPSR/CNPR Exam Study Guide
Solutions Updated
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
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,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.
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, 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.
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Solutions Updated
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
Copyright ©SOPHIABENNETT 2025 ACADEMIC YEARALL RIGHTS RESERVED. Page 1/27
,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.
Copyright ©SOPHIABENNETT 2025 ACADEMIC YEARALL RIGHTS RESERVED. Page 2/27
, 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.
Copyright ©SOPHIABENNETT 2025 ACADEMIC YEARALL RIGHTS RESERVED. Page 3/27
