AND ANSWERS
Pharma companies must submit extensive data to the FDA demonstrating the safety and
effectiveness of new drugs before receiving approval for sale. - ANS True
Average review time for a new drug - ANS 18 months
Sales Team - ANS Pg 7
The "engine of innovation," focused on discovering or inventing promising new product. -
ANS Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the business. -
ANS Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANS True
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,3,070 new meds are in development for cancer. - ANS True
Define Off-label - ANS Usage of a medication for purposes other than the specific ones
appearing on the label
Toxicity - ANS The extent, quality, or degree to which a substance is poisonous or harmful to
the body
Institutional review Board (IRB) - 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 - ANS Inactive pill, liquid, or powder that has no treatment value aka sugar pill
Edema - ANS Swelling
Asymptomatic - ANS Without signs or symptoms
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,Clinical Pharmacology - ANS The study of the effects and movement of drugs in the human
body
Anatomy - ANS The study of basic structures of the body
Physiology - ANS The study of how those body structures function
Basic clinical pharmacology involves 3 main concepts - ANS Pharmacodynamics,
Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics - 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 - 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.
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, Drug distribution & elimination - ANS Drug delivery systems, route of administration , modes
of excretion.
Plasma - ANS The liquid portion of the blood that carries proteins and other substances
Organs - ANS Specialized cells and tissues grouped together to perform specific body
function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus - ANS Brain of the cell that regulates all activities.
Proteins - ANS A nutrient made up of of chains of amino acids
Fats - ANS A nutrient stored in special body tissues as a great source of reserve energy
Carbohydrates - ANS A nutrient that is the body's immediate source of energy. It's broken
down to glucose and used for immediate metabolic reactions.
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