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# ICH Toxicokinetics Microsampling Draft Guidance Published
- URL: https://www.fdaweb.com/ich-toxicokinetics-microsampling-draft-guidance-published/
- Published: 2016-09-13T12:00:00.000Z
- Updated: 2026-09-14T21:31:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136788

FDA has published an International Council on Harmonization draft guidance, *Q&As on Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies*, with questions and answers on the assessment of systemic exposure in toxicity studies. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM519697.pdf?ref=fdaweb.com) says it focuses on points to consider before incorporating the microsampling method in toxicokinetic studies, acknowledges the benefits and some limitations for assessing toxicokinetics in main study animals and its overall important contribution to the 3R benefits (replacement, reduction, and refinement) by reducing the need for toxicokinetic satellite animals.