Issue Date: March 1, 1995
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Safety
Status: Final
S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
This Note for Guidance concerns toxicokinetics only with respect to the development of pharmaceutical products intended for use in human subjects. In this context, toxicokinetics is defined as the generation of pharmacokinetic data, either as an integral component in the conduct of nonclinical toxicity studies or in specially designed supportive studies, in order to assess systemic exposure. These data may be used in the interpretation of toxicology findings and their relevance to clinical safety issues (see Note 1 for definitions of other terms used in this document).
Download the Guidance Document
