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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
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,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
Asymptomatic - 🧠ANSWER ✔✔Without signs or symptoms
Clinical Pharmacology - 🧠ANSWER ✔✔The study of the effects and
movement of drugs in the human body
Anatomy - 🧠ANSWER ✔✔The study of basic structures of the body
Physiology - 🧠ANSWER ✔✔The study of how those body structures
function
Basic clinical pharmacology involves 3 main concepts - 🧠ANSWER
✔✔Pharmacodynamics, Pharmacokinetics, drug distribution and
elimination.
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, 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
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