ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies - Scientific guideline
Table of contents
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
questions and answers
.
Keywords: Toxicokinetics, systemic exposure, toxicology studies, concomitant toxicokinetics, study design
- ICH: safety
- Non-clinical: pharmacokinetics and toxicokinetics
ICH S3A: note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - questions and answers- ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
- ICH S1C (R2) Dose selection for carcinogenicity studies of pharmaceuticals
- ICH S3B Pharmacokinetics: repeated dose tissue distribution studies
- ICH S5 (R2) Reproductive toxicology: detection of toxicity to reproduction for medicinal products including toxicity to male fertility