S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies March 1995
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).
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