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ICCVAM Biennial Report 2018-2019

ICCVAM Biennial Report 2018-2019
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https://ntp.niehs.nih.gov/go/884527

Guidance on Microsampling Techniques in Toxicokinetics Studies

In May 2018, FDA announced availability of final guidance on the benefits and limitations of the use of microsampling techniques in toxicokinetics studies. Benefits of these techniques include reducing the numbers of animals needed for these studies. “S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling—Questions and Answers” is available on the FDA website. This international guidance was developed through FDA participation in the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH).

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