NAPSR/CNPR Exam
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
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
