Econ/Epi Exam 1 Flashcards
the study of the use of and effect of drugs in large numbers of people
pharmacoepidemiology
pharmEPI applies the methods of ___ to the content area of ___
methods of epidemiology in content area of clinical pharmacology
when is the application of pharmEPI used
after marketing, primarily post-marketing drug surveillance/phase 4
the study of effects of drugs
pharmacology
the study of the effects of drugs in humans
clinical pharmacology
the study of the distribution and determinants of diseases in populations
epidemiology
legislation in response to excessive adulteration and misbranding of food and drug at the time
pure food and drug act
legislation passed that required preclinical toxicity testing and required manufacturers to gather clinical data about a drug
food drug and cosmetic act
1st textbook and registry for AEs of drugs
AMA council of pharmacy and chemistry
type of study that is a report of an event in a single patient
case report
type of study that is a collection of patients all of whom have either a single exposure or single outcome
case series
type of study that examines trends in an exposure that is presumed cause and trends in a disease that is a presumed effect and test whether the trends coincide
analyses of secular trends (ecological studies)
type of study that compares cases (with outcomes) to controls (with outcomes) to look for differences in antecedent exposure
case control studies
type of study that identifies a cohort of subjects and follows them over time to determine an outcome
cohort study
type of study where participants are randomly assigned between exposure and control groups; artificial
randomized control trial
type of study where the investigator tests the effectiveness of an intervention under “real world” conditions
pragmatic clinical trials
ratio based on incident data or an event occurring
relative risk; risk ration
ratio used based on prevalent data
odds ration
study result where exposure and effect are independent
no association
study results that are chance (unsystematic) or bias (systematic)
artificial association
study results that are confounded
indirect association
study results that are direct or true
causal association
type of error that is tested for and fixed statistically
random
type of error that is avoided with good study design; may be information or selection
bias