Week 1, Ch 2 Flashcards
Drug schedules, Clinical trials, Classifications.
If you wanted a comprehensive medical reference of published drug standards, what might you use?
A Pharmacopoeia
What is the center for drug evaluation and research called?
The FDA
What government site determines the safety and efficacy of drugs?
The FDA
What does the FDA do?
Determines the safety and efficacy of drugs.
If you wanted to identify an extreme adverse reaction of a drug, where would you find it on the label?
The Black Box Warning
The Black Box warning is used to identify what?
An extreme reaction from a drug
True or False:
Because of the unknown effects of herbal medicine, the FDA uses more strict evaluations for Herbal supplements.
False.
Herbal supplements have much less strict evaluations
There are 4 stages of drug approval. What are they?
1.) Pre-Clinical Investigation
2.) Clinical Investigation
3.) Review of New Drug Application
4.) Post-Marketing
The Pre-Clinical evaluation usually takes:
a.) 1-3 years
b.) 2-10 years
c.) 2 months - 7 years
a.) 1 - 3 years is pre-Clinical
2-10 years is Clinical evaluation
2 months-7 years is Review of NDA
The Pre-Clinical stage determines the drug-dose range, and is tested on what?
Human cells and animals.
NOT HUMANS!!
The examination of a drug’s adverse effects begins in which stage of the drug approval process?
Pre-Clinical stage
True or False:
Results in the pre-clinical trials are considered conclusive, because the next stage involves trials on humans.
False:
The pre-clinical trials results are considered inconclusive.
True or False:
Clinical Investigation is the start of human trials.
True
Clinical Investigations has 3 stages. Which stage determines the dosage and risks?
Stage 1
In which stage of the Clinical Investigation trials do the Clinical Investigators address concerns about the drug’s efficacy and safety?
Stage 3
True or False:
During stage 2 of the Clinical Trials, the drugs are tested in small groups between 2-7 people.
False:
Stage 2 involves testing a large group of people.
True or False:
Clinical Trials are started with the clients with the targeted ailment to test for drug benefits and the speed of recovery.
False:
Clinical Trials begin with the healthiest patients first, then on the people with the targeted ailment.
In Clinical trials, do the people in the trials have to know that they are in a study?
Yes
True or False:
If the drug has shown to be effective in Clinical evaluation without serious side effects, it enters market circulation and moves on to the Post-Marketing Surveillance phase.
False:
It moves on to the NDA review phase before it can be put to market.
The time it takes to review the drug during the NDA review stage can be between 2 months and 7 years. But on average, how long does it usually take?
17 to 24 months.
True or False:
Research on human populations is continued through the Post-Market Surveillance stage, and can go on for several years.
True:
Research is continued through post-marketing surveillance and can go on from 10 to 20 years!
An Addiction to a drug is:
a.) An overwhelming feeling to use a drug repeatedly.
b.) A Physiological/Psychological need for drugs
c.) The Nervous System adaptation to drug dependance.
a.) Addiction is an overwhelming feeling to use a drug repeatedly.
Dependency on a drug is:
a.) A compelling desire for a drug
b.) An overwhelming desire to use a drug repeatedly.
c.) A Physiological/Psychological need for drugs
c.) Dependency is a physiological/psychological need for drugs.
What’s the difference between Addiction and the Dependance of a drug?
Addiction is an overwhelming urge to use a drug repeatedly.
Dependance is a physiological/Psychological need to use a drug.
