What is the Main Purpose of Preclinical Testing? Pre-clinical testing must be performed before clinical trials. The purpose of pre-clinical trials is to use human cell cultures or animals to evaluate the potential toxicity of a new therapeutic drug before the “in vivo” test is performed by human participants. The main goals of preclinical studies are to determine a starting, safe dose for first-in-human study and assess potential toxicity of the product, which typically include new medical devices , prescription drugs , and diagnostics . According to the US Food and Drug Administration (FDA), before a new medicinal drug is approved for use, a series of tests need to be carried out. In the first phase, basic research identifies hypothetical targets to treat a certain disease and then small molecules or biological compounds are screened to find any which show potential to treat the disease. Before the new vaccine can be tested in humans, preclinical testing is required to prov
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