FDA Seeks Comment on Draft Guidance for Toxicokinetics Studies

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FDA Seeks Comment on Draft Guidance for Toxicokinetics Studies

Catherine Sprankle, NICEATM

A U.S. Food and Drug Administration (FDA) notice in the September 8 Federal Register requested comments on draft guidance titled “ICH S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies—Questions and Answers.” The draft guidance facilitates interpretation of the ‘‘S3A Guidance: The Assessment of Systemic Exposure in Toxicity Studies,’’ especially to address the benefit and use of microsampling techniques in main study animals. The Q&A guidance is intended to provide points to consider before incorporating the microsampling method in toxicokinetic studies, and acknowledges the benefits (and some limitations) of the use of microsampling.

Comments on the draft guidance are requested by December 7.

Catherine Sprankle
Catherine Sprankle
Communications Specialist for NICEATM

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