19 May 2016

The Questions and Answers Document of the ICH S3A Guideline on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure reached Step 2b of the ICH Process in May 2016 and now enters the consultation period (Step 3).

The ICH S3A Q&A document has been developed to provide addition guidance and facilitate the interpretation of the S3A Guideline; and especially to address the benefit and use of microsampling techniques in main study animals.

The draft S3A Q&A document can be downloaded on the Safety Guideline page on the ICH website (Draft S3A Q&A document). You are invited to provide comments on the draft S3A Q&A document by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EU, USA, Japan, Canada and Switzerland are encouraged to submit their comments to their respective Regulatory Authorities.