Pharma companies must submit extensive data to the FDA demonstrating the safety and effectiveness of new drugs before receiving approval
for sale. ✔️True
Average review time for a new drug ✔️18 months
Sales Team ✔️Pg 7
The "engine of innovation," focused on discovering or inventing promising new product. ✔️Research & Development
This includes supply chain, manufacturing, trade, and distribution functions of the business. ✔️Manufacturing & Operations
In 2012, FDA regulators approved 39 new drugs for use in the U.S. ✔️True
3,070 new meds are in development for cancer. ✔️True
Define Off-label ✔️Usage of a medication for purposes other than the specific ones appearing on the label
Toxicity ✔️The extent, quality, or degree to which a substance is poisonous or harmful to the body
Institutional review Board (IRB) ✔️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 ✔️Inactive pill, liquid, or powder that has no treatment value aka sugar pill
Edema ✔️Swelling
Asymptomatic ✔️Without signs or symptoms
Clinical Pharmacology ✔️The study of the effects and movement of drugs in the human body
Anatomy ✔️The study of basic structures of the body
Physiology ✔️The study of how those body structures function
Basic clinical pharmacology involves 3 main concepts ✔️Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics ✔️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 ✔️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 ✔️Drug delivery systems, route of administration , modes of excretion.
Plasma ✔️The liquid portion of the blood that carries proteins and other substances
Organs ✔️Specialized cells and tissues grouped together to perform specific body function for a common purpose. (Kidney, heart, intestines, and
skin)
Nucleus ✔️Brain of the cell that regulates all activities.
Proteins ✔️A nutrient made up of of chains of amino acids
Fats ✔️A nutrient stored in special body tissues as a great source of reserve energy
Carbohydrates ✔️A nutrient that is the body's immediate source of energy. It's broken down to glucose and used for immediate metabolic
reactions.
Vitamins ✔️A nutrient substance necessary for growth, development, and normal regulation of metabolic processes. Must be taken from
outside the body.
, Minerals ✔️A nutrient necessary for bodily purposes such as the balance of body fluid
Water is NOT a nutrient ✔️True
Body's Major Systems ✔️Cardiovascular, Respiratory, nervous, musculoskeletal, reproductive, immune
Absorption ✔️How the drug passes from its side of administration into the bloodstream
Distribution ✔️How the drug is dispersed among the organs after absorption into the blood
Metabolism ✔️How the active part of a drug is metabolized into a more water-soluble compound that can be readily excreted by the kidneys
Excretion ✔️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 ✔️True
Routes of drug administration ✔️Pg 26-29
Seven rights of drug administration ✔️pg 30
Bioavailability ✔️how quickly and how much of a drug reaches its intended target site of action
Bioequivalent ✔️when they contain the same active ingredients and proceed virtually the same blood levels over time.
Therapeutic equivalence ✔️Production of the same medicinal effect
Drug elimination and Excretion ✔️pg 34
Drug Forms ✔️Pg 35-38
Patent last 20 years ✔️True
Inactive ingredients ✔️Added to provide bulk, strength, aid dissolving, color, taste, etc. IAs do not affect the body
Pharmaceutical Ingredients ✔️Pg 54
BID ✔️twice a day
Cmax ✔️Peak plasma concentration on a measuring curve
Half-life ✔️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 ✔️As needed
QD ✔️Once a day
QID ✔️Four times a day
Protein binding ✔️the ability of certain drugs to bind to plasma protein.
TID ✔️three times a day
Titration ✔️the process of adjusting drug doses to achieve the max positive therapeutic effects while minimizing adverse or side affects
Tmax ✔️Time of peak plasma concentration on a measuring curve
STAT ✔️Immediately
Primary wholesale distributors ✔️Buy most of their drugs directly from manufacturers. Legally considered authorized distributors within the
meaning of the PDMA because they usually have ongoing relationships with manufacturers
Secondary wholesale distributors ✔️Buy from a primary and other secondary wholesalers as well as manufacturers but are not considered
authorized distributors of the manufacturers within the meaning of the PDMA