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. - ANSTrue
Average review time for a new drug - ANS18 months
Sales Team - ANSPg 7
The "engine of innovation," focused on discovering or inventing promising new product. -
ANSResearch & Development
This includes supply chain, manufacturing, trade, and distribution functions of the business. -
ANSManufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANSTrue
3,070 new meds are in development for cancer. - ANSTrue
Define Off-label - ANSUsage of a medication for purposes other than the specific ones
appearing on the label
Toxicity - ANSThe extent, quality, or degree to which a substance is poisonous or harmful to
the body
Institutional review Board (IRB) - ANSA 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 - ANSInactive pill, liquid, or powder that has no treatment value aka sugar pill
Edema - ANSSwelling
Asymptomatic - ANSWithout signs or symptoms
Clinical Pharmacology - ANSThe study of the effects and movement of drugs in the human
body
Anatomy - ANSThe study of basic structures of the body
Physiology - ANSThe study of how those body structures function
Basic clinical pharmacology involves 3 main concepts - ANSPharmacodynamics,
Pharmacokinetics, drug distribution and elimination.
, Pharmacodynamics - ANSStudy 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 - ANSStudy 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 - ANSDrug delivery systems, route of administration , modes
of excretion.
Plasma - ANSThe liquid portion of the blood that carries proteins and other substances
Organs - ANSSpecialized cells and tissues grouped together to perform specific body
function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus - ANSBrain of the cell that regulates all activities.
Proteins - ANSA nutrient made up of of chains of amino acids
Fats - ANSA nutrient stored in special body tissues as a great source of reserve energy
Carbohydrates - ANSA nutrient that is the body's immediate source of energy. It's broken
down to glucose and used for immediate metabolic reactions.
Vitamins - ANSA nutrient substance necessary for growth, development, and normal
regulation of metabolic processes. Must be taken from outside the body.
Minerals - ANSA nutrient necessary for bodily purposes such as the balance of body fluid
Water is NOT a nutrient - ANSTrue
Body's Major Systems - ANSCardiovascular, Respiratory, nervous, musculoskeletal,
reproductive, immune
Absorption - ANSHow the drug passes from its side of administration into the bloodstream
Distribution - ANSHow the drug is dispersed among the organs after absorption into the
blood
Metabolism - ANSHow the active part of a drug is metabolized into a more water-soluble
compound that can be readily excreted by the kidneys
Excretion - ANSHow 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.
Pharma companies must submit extensive data to the FDA demonstrating the safety and
effectiveness of new drugs before receiving approval for sale. - ANSTrue
Average review time for a new drug - ANS18 months
Sales Team - ANSPg 7
The "engine of innovation," focused on discovering or inventing promising new product. -
ANSResearch & Development
This includes supply chain, manufacturing, trade, and distribution functions of the business. -
ANSManufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANSTrue
3,070 new meds are in development for cancer. - ANSTrue
Define Off-label - ANSUsage of a medication for purposes other than the specific ones
appearing on the label
Toxicity - ANSThe extent, quality, or degree to which a substance is poisonous or harmful to
the body
Institutional review Board (IRB) - ANSA 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 - ANSInactive pill, liquid, or powder that has no treatment value aka sugar pill
Edema - ANSSwelling
Asymptomatic - ANSWithout signs or symptoms
Clinical Pharmacology - ANSThe study of the effects and movement of drugs in the human
body
Anatomy - ANSThe study of basic structures of the body
Physiology - ANSThe study of how those body structures function
Basic clinical pharmacology involves 3 main concepts - ANSPharmacodynamics,
Pharmacokinetics, drug distribution and elimination.
, Pharmacodynamics - ANSStudy 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 - ANSStudy 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 - ANSDrug delivery systems, route of administration , modes
of excretion.
Plasma - ANSThe liquid portion of the blood that carries proteins and other substances
Organs - ANSSpecialized cells and tissues grouped together to perform specific body
function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus - ANSBrain of the cell that regulates all activities.
Proteins - ANSA nutrient made up of of chains of amino acids
Fats - ANSA nutrient stored in special body tissues as a great source of reserve energy
Carbohydrates - ANSA nutrient that is the body's immediate source of energy. It's broken
down to glucose and used for immediate metabolic reactions.
Vitamins - ANSA nutrient substance necessary for growth, development, and normal
regulation of metabolic processes. Must be taken from outside the body.
Minerals - ANSA nutrient necessary for bodily purposes such as the balance of body fluid
Water is NOT a nutrient - ANSTrue
Body's Major Systems - ANSCardiovascular, Respiratory, nervous, musculoskeletal,
reproductive, immune
Absorption - ANSHow the drug passes from its side of administration into the bloodstream
Distribution - ANSHow the drug is dispersed among the organs after absorption into the
blood
Metabolism - ANSHow the active part of a drug is metabolized into a more water-soluble
compound that can be readily excreted by the kidneys
Excretion - ANSHow 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.
