NAPSR CNPR Exam - 14th Edition Correct answers latest update
True or False?
The FDA regulates the introduction of new drugs and enforces U.S. drug laws.
True
True or False?
Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs be...
The FDA regulates the introduction of new drugs and enforces U.S. drug laws.
True
True or False?
Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness
of new drugs before receiving approval for sale.
True
What is the average review time for a new drug?
18 months
Sales Team (pg 7)
Pg 7
What is considered the "engine of innovation," focused on discovering or inventing promising new
product?
Research & Development (R&D)
What includes the supply chain, manufacturing, trade, and distribution functions of the business?
Manufacturing & Operations
True or False?
In 2012, FDA regulators approved 39 new drugs for use in the U.S.
True
True or False?
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
Define "Toxicity"
The extent, quality, or degree to which a substance is poisonous or harmful to the body
What is the 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.
,Define "Placebo"
Inactive pill, liquid, or powder that has no treatment value aka sugar pill
Define "Clinical Pharmacology"
The study of the effects and movement of drugs in the human body
3 Main Concepts of Basic Clinical Pharmacology
- Pharmacodynamics
- Pharmacokinetics
- Drug Distribution and Elimination
Define "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.
Define "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.
ADME
Define "Drug Distribution & Elimination"
- Drug delivery systems
- Route of administration
- Modes of excretion
Define "Plasma"
The liquid portion of the blood that carries proteins and other substances
Define "Organs"
Specialized cells and tissues grouped together to perform specific body function for a common
purpose. (Kidney, heart, intestines, and skin)
Define "Nucleus"
Brain of the cell that regulates all activities.
Define "Proteins"
A nutrient made up of of chains of amino acids
Define "Fats"
A nutrient stored in special body tissues as a great source of reserve energy
Define "Carbohydrates
, A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for
immediate metabolic reactions.
Define "Vitamins"
A nutrient substance necessary for growth, development, and normal regulation of metabolic
processes. Must be taken from outside the body.
Define "Minerals"
A nutrient necessary for bodily purposes such as the balance of body fluid
True or False?
Water is a nutrient
False
Water is NOT a nutrient
List the Body's Major Organ Systems
1. Cardiovascular
2. Respiratory
3. Gastrointestinal
4. Nervous
5. Musculoskeletal
6. Reproductive
7. Immune
Define "Absorption" in ADME
How the drug passes from its side of administration into the bloodstream
Define "Distribution" in ADME
How the drug is dispersed among the organs after absorption into the blood
Define "Metabolism" in ADME
How the active part of a drug is metabolized into a more water-soluble compound that can be readily
excreted by the kidneys
Define "Excretion" in ADME
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.
True or False?
It takes about 5 years for a drug to hit the market
False
It takes about 10 years for a drug to hit the market
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