Exam 1 Flashcards
What is pharmacotherapeutics?
The use of drugs for the purpose of disease prevention, diagnosis and treatment
What are therapeutic effects?
The beneficial responses to medication treatment
What are adverse effects?
The serious side effects resulting from taking a medication
What are teratogens?
Drugs that cause birth defects
What is the minimal effective concentration definition?
The amount of drug required to produce a therapeutic effect
What is a toxic concentration?
The amount of drug that results in serious adverse effects
T/F Preclinical trials are not regulated by the FDA.
True
T/F Preclinical trials are tested on animals or human microbial cells.
True
When do FDA regulations begin on drug approval?
When humans become involved as test subjects
What happens in Phase I of clinical trials?
The volunteers are all healthy.
What happens in Phase II of clinical trials?
There is a larger number of volunteers who have the specific disease for the drug being tested.
What happens in Phase III of clinical trials?
The trials are wide scale, patient’s have multiple issues and they monitor drug interactions.
What happens in Phase IV of clinical trials?
The drug is in the public and adverse effects are reported.
How long does it take for a drug to get approved for use?
12 years
What is Category X?
a drug that has demonstrated fetal abnormalities or adverse responses
What is pharmacokinetics?
How the body responds to a drug
What are the four phases of pharmacokinetics?
Absorption, distribution, metabolism, excretion
What happens in the absorption phase?
The drug is absorbed and starts going places
What happens in the distribution phase?
The drug travels to where it needs to go in the body
What is the metabolism phase?
the speed at which your body breaks down and excretes a drug
What happens in the excretion phase?
The speed at which your body rids the drug from your system
What happens in the excretion phase?
The speed at which your body rids the drug from your system
What is the primary factor that determines the onset and intensity of drug action?
Absorption
Which routes do not go through the 1st pass effect?
Sublingual and buccal