Practice questions for this set
Terms in this set (262)
NAPSR/CNPR Exam
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, 9/21/24, 5:46 PM
Pharma companies must submit extensive True
data to the FDA demonstrating the safety
and effectiveness of new drugs before
receiving approval for sale.
Average review time for a new drug 18 months
Sales Team Pg 7
The "engine of innovation," focused on Research & Development
discovering or inventing promising new
product.
This includes supply chain, manufacturing, Manufacturing & Operations
trade, and distribution functions of the
business.
In 2012, FDA regulators approved 39 new True
drugs for use in the U.S.
3,070 new meds are in development for True
cancer.
Usage of a medication for purposes other than the specific ones appearing on the
Define Off-label
label
Toxicity The extent, quality, or degree to which a substance is poisonous or harmful to the body
A committee of physicians, staticians, community advocated, and others which ensure
Institutional review Board (IRB) 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 Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
concepts
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
Pharmacodynamics
effects of drugs (pain relief, blood pressure reduction, their side effects and their sites
of action.
Study of how a drug is processed by the body, with emphasis on the time required for
Pharmacokinetics 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
Specialized cells and tissues grouped together to perform specific body function for a
Organs
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
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