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