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