NAPSRx/CNPR Study Guide-Latest Update-The FDA regulates the introduction of new drugs and enforces U.S. drug laws. True
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 ...
The FDA regulates the introduction of new drugs and enforces U.S. drug laws.
True
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
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
Basic clinical pharmacology involves 3 main concepts
Pharmacodynamics, Pharmacokinetics, drug distribution and elimination.
Pharmacodynamics
, Latest Update
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
Nucleus
Brain of the cell that regulates all activities.
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
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
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