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