ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies - Scientific guideline

This document provides an understanding of the meaning and application of toxicokinetics and guidance on developing test strategies in toxicokinetics. It highlights the need to integrate pharmacokinetics into toxicity testing. Read together with the Draft ICH guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - Questions and answers - First version.

Keywords: Toxicokinetics, systemic exposure, toxicology studies, concomitant toxicokinetics, study design

Current effective version

ICH: S 3 A: Toxicokinetics: A guidance for assessing systemic exposure in toxicology studies - Step 5

AdoptedLegal effective date: 01/06/1995Reference Number: CPMP/ICH/384/95