AND ANSWERS 100% CORRECT!!
Pharma companies must submit extensive data to the FDA demonstrating the safety
and effectiveness of new drugs before receiving approval for sale. - ANSWER True
Average review time for a new drug - ANSWER 18 months
Sales Team - ANSWER Pg 7
The "engine of innovation," focused on discovering or inventing promising new
product. - ANSWER Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the
business. - ANSWER Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANSWER True
3,070 new meds are in development for cancer. - ANSWER True
Define Off-label - ANSWER Usage of a medication for purposes other than the
specific ones appearing on the label
Toxicity - ANSWER The extent, quality, or degree to which a substance is poisonous
or harmful to the body
,Institutional review Board (IRB) - 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.
Placebo - ANSWER Inactive pill, liquid, or powder that has no treatment value aka
sugar pill
Edema - ANSWER Swelling
Pharmacodynamics - 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 - 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 - ANSWER Drug delivery systems, route of
administration , modes of excretion.
Plasma - ANSWER The liquid portion of the blood that carries proteins and other
substances
Organs - ANSWER Specialized cells and tissues grouped together to perform
specific body function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus - ANSWER Brain of the cell that regulates all activities.
Proteins - ANSWER A nutrient made up of of chains of amino acids
Fats - ANSWER A nutrient stored in special body tissues as a great source of
reserve energy
, Carbohydrates - 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 - ANSWER A nutrient substance necessary for growth, development, and
normal regulation of metabolic processes. Must be taken from outside the body.
Minerals - ANSWER A nutrient necessary for bodily purposes such as the balance of
body fluid
Water is NOT a nutrient - ANSWER True
Body's Major Systems - ANSWER Cardiovascular, Respiratory, nervous,
musculoskeletal, reproductive, immune
Absorption - ANSWER How the drug passes from its side of administration into the
bloodstream
Distribution - ANSWER How the drug is dispersed among the organs after
absorption into the blood
Metabolism - 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 - 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.
It takes about 10 years for a drug to hit the market - ANSWER True
Routes of drug administration - ANSWER Pg 26-29
Seven rights of drug administration - ANSWER pg 30
Bioavailability - ANSWER how quickly and how much of a drug reaches its intended
target site of action