Toxicokinetics in preclinical evaluation.

Toxicokinetic evaluation is both a regulatory and scientific requirement in the drug development process. However, as a fairly new term, its use within the industry is still confused. Toxicokinetics is the generation of kinetic data to assess systemic exposure, either as an integral component of preclinical toxicity studies, or in specially designed supportive studies. These data help to understand the relationship between observed toxicity and administered dose. They also play a role in the clinical setting, assisting in the setting of plasma limits for early human exposure and in the calculation of safety margins.