NAPSR/CNPR Certification Exam – Complete Study
Guide (Qs & As)
Pharma companies must submit extensive data to the FDA demonstrating the
safety and effectiveness of new drugs before receiving approval for sale.
Right Ans - True
Average review time for a new drug Right Ans - 18 months
The FDA regulates the introduction of new drugs and enforces U.S. drug laws.
Right Ans - True
In 2012, FDA regulators approved 39 new drugs for use in the U.S. Right
Ans - True
Sales Team Right Ans - Pg 7
The "engine of innovation," focused on discovering or inventing promising
new product. Right Ans - Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of
the business. Right Ans - Manufacturing & Operations
3,070 new meds are in development for cancer. Right Ans - True
Define Off-label Right Ans - Usage of a medication for purposes other than
the specific ones appearing on the label
Toxicity Right Ans - The extent, quality, or degree to which a substance is
poisonous or harmful to the body
Institutional review Board (IRB) Right Ans - 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 Right Ans - Inactive pill, liquid, or powder that has no treatment
value aka sugar pill
,Edema Right Ans - Swelling
Asymptomatic Right Ans - Without signs or symptoms
Clinical Pharmacology Right Ans - The study of the effects and movement
of drugs in the human body
Anatomy Right Ans - The study of basic structures of the body
Physiology Right Ans - The study of how those body structures function
Basic clinical pharmacology involves 3 main concepts Right Ans -
Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics Right Ans - 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 Right Ans - 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 Right Ans - Drug delivery systems, route of
administration , modes of excretion.
Plasma Right Ans - The liquid portion of the blood that carries proteins and
other substances
Organs Right Ans - Specialized cells and tissues grouped together to
perform specific body function for a common purpose. (Kidney, heart,
intestines, and skin)
Nucleus Right Ans - Brain of the cell that regulates all activities.
Proteins Right Ans - A nutrient made up of of chains of amino acids
, Fats Right Ans - A nutrient stored in special body tissues as a great source
of reserve energy
Carbohydrates Right Ans - A nutrient that is the body's immediate source
of energy. It's broken down to glucose and used for immediate metabolic
reactions.
Vitamins Right Ans - A nutrient substance necessary for growth,
development, and normal regulation of metabolic processes. Must be taken
from outside the body.
Minerals Right Ans - A nutrient necessary for bodily purposes such as the
balance of body fluid
Water is NOT a nutrient Right Ans - True
Body's Major Systems Right Ans - Cardiovascular, Respiratory, nervous,
musculoskeletal, reproductive, immune
Absorption Right Ans - How the drug passes from its side of administration
into the bloodstream
Distribution Right Ans - How the drug is dispersed among the organs after
absorption into the blood
Metabolism Right Ans - How the active part of a drug is metabolized into a
more water-soluble compound that can be readily excreted by the kidneys
Excretion Right Ans - 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 Right Ans - True
Routes of drug administration Right Ans - Pg 26-29
Seven rights of drug administration Right Ans - pg 30
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