answers latest update guaranteed success
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
This includes supply chain, manufacturing, trade, and distribution functions of the business. -
ANS Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. - ANS True
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
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.
Placebo - ANS Inactive pill, liquid, or powder that has no treatment value aka sugar pill
Edema - ANS Swelling
Asymptomatic - ANS Without signs or symptoms
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 excretion.
Plasma - ANS The liquid portion of the blood that carries proteins and other substances
Organs - ANS Specialized cells and tissues grouped together to perform specific body
function for a common purpose. (Kidney, heart, intestines, and skin)
Nucleus - ANS Brain of the cell that regulates all activities.
Proteins - ANS A nutrient made up of of chains of amino acids
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
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
Water is NOT a nutrient - ANS True
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
Excretion - ANS 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 - ANS True
Routes of drug administration - ANS Pg 26-29
Seven rights of drug administration - ANS pg 30
Bioavailability - ANS how quickly and how much of a drug reaches its intended target site of
action
Bioequivalent - ANS when they contain the same active ingredients and proceed virtually the
same blood levels over time.
Therapeutic equivalence - ANS Production of the same medicinal effect
Drug elimination and Excretion - ANS pg 34
Drug Forms - ANS Pg 35-38
Patent last 20 years - ANS True
Inactive ingredients - ANS Added to provide bulk, strength, aid dissolving, color, taste, etc.
IAs do not affect the body
Pharmaceutical Ingredients - ANS Pg 54
BID - ANS twice a day
Cmax - ANS Peak plasma concentration on a measuring curve
Half-life - ANS Period of time it takes for a specific amount of drug in the body to be reduced,
through the excretion or elimination process, to exactly one-half that original amount
PRN - ANS As needed
QD - ANS Once a day