The basic purpose of preclinical tests is to gather enough information through laboratory experimentation and animal tests to determine whether the drug is sufficiently safe for trials in humans. 21 C.F.R. § 312.23(8); Ex. 6, at 10.

Before studying a new medicine in humans, a pharmaceutical company must conduct a series of laboratory and animalstudies to test how the medicine works andassessits safety. (21 C.F.R. § 312.23(a)(8).) Ifthe results are promising, the company submits an Investigational New Drug application (“IND”) to the FDA, outlining the preclinical study results and offering a plan for clinical tnals in humans.