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,...
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