Adversity Considerations for Thyroid Follicular Cell Hypertrophy and Hyperplasia in Nonclinical Toxicity Studies: Results From the 6th ESTP International Expert Workshop
Toxicologic Pathology, vol. 48, pp. 920–938
Abstract
The European Society of Toxicologic Pathology organized an expert workshop in May 2018 to address adversity considerations related to thyroid follicular cell hypertrophy and/or hyperplasia (FCHH), which is a common finding in nonclinical toxicity studies that can have important implications for risk assessment of pharmaceuticals, food additives, and environmental chemicals. The broad goal of the workshop was to facilitate better alignment in toxicologic pathology and regulatory sciences on how to determine adversity of FCHH. Key objectives were to describe common mechanisms leading to thyroid FCHH and potential functional consequences; provide working criteria to assess adversity of FCHH in context of associated findings; and describe additional methods and experimental data that may influence adversity determinations. The workshop panel was comprised of representatives from the European Union, Japan, and the United States. Participants shared case examples illustrating issues related to adversity assessments of thyroid changes. Provided here are summary discussions, key case presentations, and panel recommendations. This information should increase consistency in the interpretation of adverse changes in the thyroid based on pathology findings in nonclinical toxicity studies, help integrate new types of biomarker data into the review process, and facilitate a more systematic approach to communicating adversity determinations in toxicology reports.
Authors 22
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Maike Huisinga corresponding
Affiliation as printed
BASF SE, Ludwigshafen, Germany
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Charles River Laboratories, Saint-Germain-Nuelles, France
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Janssen Pharmaceutical Companies of Johnson & Johnson, Beerse, Belgium
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Bayer CropScience, Sophia Antipolis, France
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Ionis Pharmaceuticals (United States)
Affiliation as printed
Ionis Pharmaceuticals Inc, Carlsbad, CA, USA
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Center for Food Safety and Applied Nutrition · United States Food and Drug Administration
Affiliation as printed
Center for Food Safety and Applied Nutrition (CFSAN), US Food and Drug Administration, College Park, MD, USA
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Affiliation as printed
Bayer AG, Wuppertal, Germany
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The Institute of Environmental Toxicology
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Institute of Environmental Toxicology, Ibaraki, Japan
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Darmstadt, Germany
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Bad Duerkheim, Germany
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Novo Nordisk A/S, Maløv, Denmark
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Charité - Universitätsmedizin Berlin
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Charité University Medicine Berlin, Berlin, Germany
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Roche Pharma Research and Development, Basel, Switzerland
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The Dow Chemical Company, Midland, MI, USA
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BASF SE, Limburgerhof, Germany
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Pfizer Inc, Groton, CT, USA
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Boehringer Ingelheim (Germany)
Affiliation as printed
Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany
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Affiliation as printed
Ohio University, Athens, OH, USA
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BASF SE, Ludwigshafen, Germany
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Charles River Laboratories (Netherlands)
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Charles River Laboratories, Den Bosch, The Netherlands
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Boehringer Ingelheim (United States)
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Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA
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Affiliation as printed
Food Safety Commission of Japan, Tokyo, Japan
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