100% CORRECT ANSWERS .
Pharma companies must submit extensive data to the FDA demonstrating the safety and
effectiveness of new drugs before receiving approval for sale. - Correct Answer -True
Average review time for a new drug - Correct Answer -18 months
Sales Team - Correct Answer -Pg 7
The "engine of innovation," focused on discovering or inventing promising new product. -
Correct Answer -Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the business. -
Correct Answer -Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - Correct Answer -True
3,070 new meds are in development for cancer. - Correct Answer -True
Define Off-label - Correct Answer -Usage of a medication for purposes other than the
specific ones appearing on the label
Toxicity - Correct Answer -The extent, quality, or degree to which a substance is poisonous
or harmful to the body
Institutional review Board (IRB) - Correct Answer -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.
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,Placebo - Correct Answer -Inactive pill, liquid, or powder that has no treatment value aka
sugar pill
Edema - Correct Answer -Swelling
Asymptomatic - Correct Answer -Without signs or symptoms
Clinical Pharmacology - Correct Answer -The study of the effects and movement of drugs in
the human body
Anatomy - Correct Answer -The study of basic structures of the body
Physiology - Correct Answer -The study of how those body structures function
Basic clinical pharmacology involves 3 main concepts - Correct Answer -
Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics - Correct Answer -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 - Correct Answer -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 - Correct Answer -Drug delivery systems, route of
administration , modes of excretion.
Plasma - Correct Answer -The liquid portion of the blood that carries proteins and other
substances
Organs - Correct Answer -Specialized cells and tissues grouped together to perform specific
body function for a common purpose. (Kidney, heart, intestines, and skin)
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, Nucleus - Correct Answer -Brain of the cell that regulates all activities.
Proteins - Correct Answer -A nutrient made up of of chains of amino acids
Fats - Correct Answer -A nutrient stored in special body tissues as a great source of reserve
energy
Carbohydrates - Correct Answer -A nutrient that is the body's immediate source of energy.
It's broken down to glucose and used for immediate metabolic reactions.
Vitamins - Correct Answer -A nutrient substance necessary for growth, development, and
normal regulation of metabolic processes. Must be taken from outside the body.
Minerals - Correct Answer -A nutrient necessary for bodily purposes such as the balance of
body fluid
Water is NOT a nutrient - Correct Answer -True
Body's Major Systems - Correct Answer -Cardiovascular, Respiratory, nervous,
musculoskeletal, reproductive, immune
Absorption - Correct Answer -How the drug passes from its side of administration into the
bloodstream
Distribution - Correct Answer -How the drug is dispersed among the organs after absorption
into the blood
Metabolism - Correct Answer -How the active part of a drug is metabolized into a more
water-soluble compound that can be readily excreted by the kidneys
Excretion - Correct Answer -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.
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