FDA guidance

S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in…

FDA guidance · Final · issued May 9, 2018

Key facts

Title S3A Guidance: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies: Focus on Microsampling
Status Final
Issue date May 9, 2018
Center Center for Drug Evaluation and Research
Issuing office Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research
Communication type Guidance Document
Regulated product Drugs
Docket number FDA-2016-D-2513
Open for comment No
Document on fda.gov fda.gov

At a glance

  • None Product codes referenced
  • None Recognized standards referenced

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About FDA guidance documents

FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.

Source: U.S. Food and Drug Administration (FDA), Guidance Documents

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