phases des essais clinique Flashcards
Dose-ranging on healthy volunteers for safety.
phase 1
Testing of drug on more participants to assess efficacy, effectiveness, safety and side effects.
phase 2
Testing of drug in non-human subjects to gather efficacy, toxicity and pharmacokinetic information.
preclinical
Post marketing surveillance in public, after approval from the regulatory body.
phase 4
Pharmacokinetics; particularly oral bioavailability and half-life of the drug.
phase 0
Testing of drug on even more participants to assess efficacy and side effects and compare the drug to existing medications for the same condition.
phase 3
double-blind
double aveugle
randomized
randomiser
open label
étude ouverte
non-randomized
non aléatoire
cross sectional study
analyse transversale ( a type of observational study that analyzes data on exposure and outcome from a (representative) population at a specific point in time (like a “snapshot”). )
clinical trial
essai clinique ( a type of study where researchers introduce an intervention and study the effects. This type of study is usually randomized, meaning the subjects are grouped by chance )
cohort study
étude de cohorte ( a particular form of longitudinal study that samples a group of people who share a defining characteristic, typically those who experienced a common event in a selected period, such as birth or graduation, performing a cross-section at intervals through time. )
case control study
étude cas témoin ( a type of study in which researchers identify people with an existing health problem (“cases”) and a similar group without the problem (“controls”) and then compare them with respect to an exposure. )
a case study
étude de cas ( involves an up-close, in-depth, and detailed examination of a particular case or cases, within a real-world context. )
