ANSWERS ALL VERIFIED BY
AN EXPERT A+ GRADED
(LATEST UPDATE)
,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
K
This includes supply chain, manufacturing, trade, and distribution functions of the business. -
ANS Manufacturing & Operations
C
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANS True
LO
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
YC
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.
D
Placebo - ANS Inactive pill, liquid, or powder that has no treatment value aka sugar pill
U
Edema - ANS Swelling
Asymptomatic - ANS Without signs or symptoms
ST
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.
Drug distribution & elimination - ANS Drug delivery systems, route of administration , modes of
K
excretion.
Plasma - ANS The liquid portion of the blood that carries proteins and other substances
C
Organs - ANS Specialized cells and tissues grouped together to perform specific body function
for a common purpose. (Kidney, heart, intestines, and skin)
LO
Nucleus - ANS Brain of the cell that regulates all activities.
Proteins - ANS A nutrient made up of of chains of amino acids
YC
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.
Vitamins - ANS A nutrient substance necessary for growth, development, and normal
D
regulation of metabolic processes. Must be taken from outside the body.
Minerals - ANS A nutrient necessary for bodily purposes such as the balance of body fluid
U
Water is NOT a nutrient - ANS True
ST
Body's Major Systems - ANS Cardiovascular, Respiratory, nervous, musculoskeletal,
reproductive, immune
Absorption - ANS How the drug passes from its side of administration into the bloodstream
Distribution - ANS How the drug is dispersed among the organs after absorption into the blood
Metabolism - ANS How the active part of a drug is metabolized into a more water-soluble
compound that can be readily excreted by the kidneys
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