PM- FUNDAMENTAL CONCEPTS Flashcards
The study of drugs and their interactions with living systems.
The study of biological effects of chemicals.
It encompasses the study of physical and chemical properties of drugs as well as their biochemical and physiologic effects.
Also includes knowledge of history, sources, and uses of drugs as well as knowledge of drug absorption, distribution, metabolism, and excretion.
Pharmacology
any chemical that can affect living processes.
Drug
also called as,_______ branch of pharmacology that uses drugs to treat, prevent, and diagnose disease. This addresses 2 key concerns - the drug’s effect on the body and the body’s response to the drug
Clinical pharmacology - pharmacotherapeutics
what are the two sources of drugs
- natural sources (plants ex lagundi marijuana, animal products(insulin sources), inorganic compounds-aluminum for hyperacidity,)
- synthetic drugs- commercially prepared medications
chemicals that may have therapeutic value are tested on laboratory animals for 2 main purposes:
Preclinical trials
chemicals that stay within reasonable safety margins and therapeutic at doses proceed to______
from preclinical phase TO phase 1
for preclinical trials what do they use to test the chemical
animals (rats)
in this phase they use human volunteers to test the drugs. More tightly controlled than preclinical trials and one performed by specially trained clinical investigators
Phase 1 Studies
what type of subjects do they prefer in a Phase 1 studies
healthy young men
T OR F: in phase 1 studies, despite the undesirable effects some chemicals move to the next stage of testing
TRUE
allows clinical investigators to try out the drug in patients who have the disease that the drug is designed for.
Phase II Studies -
T OR F: PHASE 2 Usually performed at various sites - in hospitals, clinics, doctors’ offices - and are monitored by representatives of the pharmaceutical company studying the drug.
T
- involve use of the drug in a vast clinical market. nformation will be collected by the drug company and shared with FDA (Food and Drug Administration).
Phase III Studies
committees of experts familiar with the specialty area in which the drugs will be used.
Food and Drug Administration Approval
How long can drug development and approval process take?
5-6 years
how is an approved drug named?
An approved drug is given the brand name by the pharmaceutical company that developed it
phase IV studies is also known as?
Postmarketing Surveillance, continual evaluation.
Prescribers are obligated to report to FDA any untoward or unexpected adverse effects associated with the drugs.
Some drugs cause unexpected effects that are not seen until wide distribution occurs.
Phase IV Studies
original designation that the drug was given when the drug company applied for the approval process.
Generic Name - also Nonproprietary Name,
given by the pharmaceutical company that developed the drug.
Brand Name - also Trade or Proprietary Name
reflect the chemical structure of a drug
Chemical Names
