Lecture 1- Principles of Pharmacology Flashcards
pharmacotherapeutics
drugs used to prevent, treat, or diagnose a disease
2 components: pharmacodynamics and pharmokinetics
pharmacokinetics
study of how a drug is absorbed, distributed or eliminated from the body
pharmacodynamics
analysis of what the drug does to the body at the systemic and cellular level
Why are generic drugs often substituted for a brand name drug?
they are cheaper and are tested to ensure that they are equal in all aspects to the brand name drug
What is the potential negative consequence of a generic drug?
some patients tend to have more side effects or different reactions to generic drugs
Which organization monitors and approves new drugs in the US?
Food and drug administration (FDA)
Describe the testing order for a new drug to be approved
preclinical testing on animals
clinical testing on humans
-phase I
-phase II
-phase III
Phase IV-no set duration
Which phase of testing is tested on 10-100 healthy subjects to help determine pharmokinetic parameters?
phase I
Which phase of clinical testing is tested on 50-500 subjects with a specific disease and clinical benefits of the drug and a broader range of toxicities can be determined in this phase?
phase II
Which phase of clinical testing is tested on several hundred to thousand subjects to establish safety and efficacy under the conditions of proposed use?
phase III
Describe off-label prescribing
Observation during clinical testing reveals a drug can effectively treat a different condition which allows for physicians to prescribe drugs for reasons other than what was originally intended
Which law was developed in 1970 to place drugs in categories based on likelihood of addiction or abuse and what are the categories?
controlled substances act, 5 categories (schedule I-V)
t/f, drugs have to have a high enough dosage so that they can reach a target tissue
true, needs to have high enough to have an effect, but not too high so that it becomes toxic
This term is the minimum dose to cause cellular changes (aka minimum effective dose)
threshold dose
This term describes doses above this level will not result in further change
ceiling effect or maximum dose
this term describes the amount of drug needed to produce a given effect or dose that produces a given response in a specific amplitude
potency
If you have two drugs, A and B, and drug A produces an effect at a much lower dose than drug B, which is more potent?
Drug A
This term is the concentration of the drug at which 50% of the population respond to it in an expected manner. Example: the dose of a pain killer where 50% of the population report an absence of pain
median effective dose (ED50)
This term is as a dose is continuously increased more and more people will have an adverse effect, the dose at which 50% of the population exhibit the specific adverse effect
median toxic dose (TD50)
This term is the dose that causes death in 50% of the animals it was tested on
median lethal dose (LD50)