U.S. flag An official website of the United States government
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies
  1. Regulatory Information

GUIDANCE DOCUMENT

S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies March 1995

Final

S3A Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This Note for Guidance concerns toxicokinetics only with respect to the development of pharmaceutical products intended for use in human subjects. In this context, toxicokinetics is defined as the generation of pharmacokinetic data, either as an integral component in the conduct of nonclinical toxicity studies or in specially designed supportive studies, in order to assess systemic exposure. These data may be used in the interpretation of toxicology findings and their relevance to clinical safety issues (see Note 1 for definitions of other terms used in this document).


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.