Intro to Pharmacology Flashcards
what occurs during pre-clinical phase of drug trials?
submit data that drug is reasonably safe for initial small-scale clinical studies via in vitro, animal studies, or foreign marketing experience
what do animal and cell culture toxicity studies show?
genotoxicity. toxicity of metabolites, basic elimination data
what occurs during phase I clinical trials?
introduction into a small number of HEALTHY human volunteers after establish reasonable safety
what is the goal of phase I clinical trials?
determine drug’s pharmacokinetics and pharmacodynamics
and eval drug metabolism, structure activity relationship, MOA
what occurs during phase II clinical trials
tested on small populations (100-200) with the disease for which the medication is indicated
what is the goal of phase II clinical trials?
preliminary assessment of efficacy
helps determine short term side effects
what occurs during phase III clinical trials
controlled and uncontrolled trials, labeling is approved
what is the goal of phase III clinical trials
gather more info about efficacy, safety, and benefit/risk relationship
what approves product labeling?
the FDA, and an Abbreviated New Drug Application (ANDA) must be filed for approval for change
what occurs during phase IV clinical trials
post marketing surveillance where adverse events are reported from a large, diverse population
what is the goal of phase IV clinical trials
ID of idiosyncratic and rare side effects
how long are OTC rx valid
1 year from write date
how long are legend (non OTC) drug rx valid? (
1 year from date written unless drug is controlled by Drug Enforcement Agency due to risk of abuse
regulation for schedule II medications?
Rx must be written, cannot be refilled
to get around this, write multiple rx with correct date, and write do not fill before date
regulation for refills for schedule III
up to 5 refills in 6 months
