Society of Toxicologic Pathology Position Paper: Review Series: Assessment of Circulating Hormones in Nonclinical Toxicity Studies: General Concepts and Considerations

Author:

Stanislaus Dinesh1,Andersson Håkan2,Chapin Robert3,Creasy Dianne4,Ferguson Duncan5,Gilbert Mary6,Rosol Thomas J.7,Boyce Rogely Waite8,Wood Charles E.9

Affiliation:

1. Reproductive Toxicology, Safety Assessment, GlaxoSmithKline, King of Prussia, Pennsylvania, USA

2. Department of Clinical Pathology, Safety Assessment, AstraZeneca R&D, Södertälje, Sweden

3. Pfizer Global R&D, Groton, Connecticut, USA

4. Huntingdon Life Sciences, East Millstone, New Jersey, USA

5. Comparative Biosciences, University of Illinois at Urbana-Champaign, College of Veterinary Medicine, Urbana, Illinois, USA

6. Toxicity Assessment Division, National Health and Environmental Effects Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, USA

7. College of Veterinary Medicine, The Ohio State University, Columbus, Ohio, USA

8. Comparative Biology and Safety Sciences, Amgen, Thousand Oaks, California, USA

9. Integrated Systems Toxicology Division, National Health and Environmental Effects Laboratory, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, USA

Abstract

This is an introductory paper to a series of papers intended to provide the basis for understanding the contribution of endocrine axis disruption or dysfunction to the pathogenesis of morphological findings and to aid in the interpretation of study outcomes. This is the first in this series of guidance papers prepared by the Working Group and outlines general concepts of study design and assay conduct and validation for hormone studies in general.

Publisher

SAGE Publications

Subject

Cell Biology,Toxicology,Molecular Biology,Pathology and Forensic Medicine

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