Prepared by the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM)
and the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative
Toxicological Methods (NICEATM)
National Institute of Environmental Health Sciences
National Institutes of Health
U.S. Public Health Service
Department of Health and Human Services
Table of Contents
Note: This document replaces the Evaluation of the Validation Status of
Toxicological Methods: General Guidelines for Submissions to
ICCVAM
(NIH Publication No. 99-4496; rev. Oct. 20, 1999)
Documents are in PDF format. Download Adobe Acrobat Reader
here.
ICCVAM - NICEATM Overview
Table of Contents
Agency Representatives
[View Current Representative List]
Preface
1.0 Introduction
2.0 ICCVAM Test Method Nomination and Submission Process
3.0 Performance Standards for Test Methods
4.0 Submission Guidelines for Proposed Test Methods
- Introduction and Rationale for the Proposed Test Method
- Test Method Protocol Components
- Substances Used for Validation of the Proposed Test Method
- In Vivo Reference Data Used to Assess the Accuracy of the Proposed Test Method
- Test Method Data and Results
- Test Method Accuracy
- Test Method Reliability (Repeatability/Reproducibility)
- Test Method Data Quality
- Other Scientific Reports and Reviews
- Animal Welfare Considerations (Refinement, Reduction, and Replacement)
- Practical Considerations
- References
- Supporting Materials
5.0 References
Appendices
- Outline for Nominations and Submissions to ICCVAM
- Suggested Formats for Presenting Data
- Glossary
- ICCVAM Validation and Regulatory Acceptance Criteria
- ICCVAM Authorization Act of 2000 (Public Law 106-545)
Submission or Nomination:
Send nominations and submissions by
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