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

This document answers questions concerning the issues addressed in the ICH S3A Toxicokinetics: the assessment of systemic exposure in toxicity studies.

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

Current effective version

ICH Guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - Questions and answers - Step 5 - First version

Adopted Reference Number: EMA/CHMP/ICH/320985/2016 Summary:

The S3A guideline was successfully implemented in 1994. However, in recent years, analytical method sensitivity has improved, allowing microsampling techniques to be widely used in toxicokinetic (TK) assessment. This Q&A document focuses on points to consider before incorporating the microsampling method in TK studies, acknowledges its benefits, and some limitations, for assessment of TKs in main study animals and its overall important contribution to the 3Rs benefits (Replacement, Reduction and Refinement) by reducing or eliminating the need for TK satellite animals.

Document history

Draft ICH guideline S3A: Note for guidance on toxicokinetics: the assessment of systemic exposure in toxicity studies - Questions and answers - First version

Draft: consultation closed Consultation dates: 31/05/2016 to 31/08/2016 Reference Number: EMA/CHMP/ICH/320985/2016 Summary:

The S3A Guideline has been successfully implemented in 1994 and, in recent years, analytical method sensitivity has improved, allowing microsampling techniques to be widely used in Toxicokinetic (TK) assessment. This Q&A document focuses on points to consider before incorporating the microsampling method in TK studies, acknowledges its benefits (and some limitations) for assessment of TKs in main study animals and its overall important contribution to the 3Rs benefits (Replacement, Reduction and efinement) by reducing or eliminating the need for TK satellite animals.