Preclinical Evidence is not conducted with humans, but in a laboratory setting. There are two main types of preclinical evidence: in vitro and in vivo studies. In vitro means "in glass" because it is typically conducted using petri dishes containing isolated cell lines. In vivo studies are conducted in animals where the animals are given doses of the test agent. Because of the inherent differences between isolated cells/ animals and humans, the results of preclinical studies do not necessarily translate into similar effects in humans. Preclinical findings provide information to guide further studies in humans.
- Source of preliminary information guiding human investigations
- Results cannot be directly extrapolated to humans
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