The FDA assesses toxicity through a series of preclinical and clinical studies. Preclinical studies often involve [in vitro](href) (test tube or cell culture) and [in vivo](href) (animal) testing to evaluate the potential toxic effects of a substance. These studies aim to identify the [toxic dose](href) levels and possible adverse effects. If a substance passes preclinical testing, it proceeds to [clinical trials](href) involving human participants, where its safety and efficacy are further evaluated.
