S3A - S3B Toxicokinetics and Pharmacokinetics
S3A Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
The ICH Harmonised Guideline was finalized under Step 4 in October 1994. This document gives guidance on developing test strategies in toxicokinetics and highlights the need to integrate pharmacokinetics into toxicity testing, in order to aid in the interpretation of the toxicology findings and promote rational study design development.
Date of Step 4: 27 October 1994
Status: Step 5
S3A Q&As Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Micro-sampling
This S3A Implementation Working Group (IWG) was endorsed by the ICH Steering Committee in October 2014.
Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the S3A Guideline on toxicokinetics have resulted in the need for some clarification.
The Questions and Answers developed by the S3A Implementation Working Group (IWG) are intended to facilitate the implementation of the S3A Guideline and especially to address the benefit and use of microsampling techniques in main study animals.
Date of Step 4:
16 November 2017
Status: Step 5
Questions and Answers (Click the links below for complete guidelines)
Endorsed Documents (Click the links below for complete guidelines)
WG Presentations / Trainings (Click the links below for complete guidelines)
S3B Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies
The ICH Harmonised Guideline was finalized under Step 4 in October 1994. This document gives guidance on circumstances when repeated dose tissue distribution studies should be considered (e.g., when appropriate data cannot be derived from other sources). It also gives recommendations on the conduct of such studies.
Date of Step 4: 27 October 1994
Status: Step 5
*These Guidelines Belongs to ICH website.
