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(INHAND): Nonproliferative and Proliferative Lesions of the Minipig

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(INHAND): Nonproliferative and Proliferative Lesions of the Minipig Invited Review Toxicologic Pathology 2021, Vol. 49(1) 110-228 ª The Author(s) 2021 International Harmonization Article reuse guidelines: sagepub.com/journals-permissions of Nomenclature and Diagnostic DOI: 10.1177/0192623320975373 journals.sagepub.com/home/tpx Criteria (INHAND): Nonproliferative and Proliferative Lesions of the Minipig Mikala Skydsgaard1 , Zuhal Dincer2, Wanda M. Haschek3, Kris Helke4, Binod Jacob5, Bjoern Jacobsen6, Gitte Jeppesen7, Atsuhiko Kato8, Hiroaki Kawaguchi9, Sean McKeag2, Keith Nelson10 , Susanne Rittinghausen11, Dirk Schaudien11, Vimala Vemireddi12, and Zbigniew W. Wojcinski13 Abstract The INHAND (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions) Project (www.toxpath.org/ inhand.asp) is a joint initiative of the Societies of Toxicologic Pathology from Europe (ESTP), Great Britain (BSTP), Japan (JSTP), and North America (STP) to develop an internationally accepted nomenclature for proliferative and nonproliferative lesions in laboratory animals. The purpose of this publication is to provide a standardized nomenclature for classifying microscopic lesions observed in most tissues and organs from the minipig used in nonclinical safety studies. Some of the lesions are illustrated by color photomicrographs. The standardized nomenclature presented in this document is also available electronically on the internet (http://www.goreni.org/). Sources of material included histopathology databases from government, academia, and industrial laboratories throughout the world. Content includes spontaneous lesions as well as lesions induced by exposure to test materials. Relevant infectious and parasitic lesions are included as well. A widely accepted and utilized international harmonization of nomenclature for lesions in laboratory animals will provide a common language among regulatory and scientific research organizations in different countries and increase and enrich international exchanges of information among toxicologists and pathologists. Keywords minipig, pathology, toxicopathology, nomenclature, background findings, INHAND 1 Novo Nordisk A/S, Ma˚løv, Denmark 9 Kagoshima University, Kagoshima, Japan 2 Pathology Department, Covance Laboratories Limited, Harrogate, United 10 Charles River Laboratories, Mattawan, MI, USA Kingdom 11 Fraunhofer Institute for Toxicology and Experimental Medicine ITEM, 3 Department of Pathobiology, University of Illinois, Urbana, IL, USA Hannover, Germany 4 Medical University of South Carolina, Charleston, SC, USA 12 Covance Laboratories, Chantilly, VA, USA 5 Merck & Co, Inc, West Point, PA, USA 13 Toxicology & Pathology Consulting, LLC, Ann Arbor, MI, USA 6 Roche Pharmaceutical Research and Early Development, Pharmaceutical Sciences, Roche Innovation Center, Basel, Switzerland Corresponding Author: 7 Charles River Laboratories Copenhagen, Lille Skensved, Denmark Mikala Skydsgaard, Novo Nordisk A/S, Ma˚løv, Denmark. 8 Chugai Pharmaceutical Co, Ltd Research Division, Shizuoka, Japan Email: [email protected] Skydsgaard et al. 111 Table of Contents specific context of a given study may require deviation from this standardized nomenclature and diagnostic criteria. The appro- Chapter 1. Introduction priate diagnoses are ultimately based upon the scientific judg- Chapter 2. Systemic Pathology ment of the study pathologist. Chapter 3. Cardiovascular System The present publication provides standardized terms and Chapter 4. Digestive System diagnostic criteria for histopathologic observations to be used Chapter 5. Endocrine System in nonclinical toxicology studies conducted in the minipig (Sus Chapter 6. Hematopoietic and Lymphoid System scrofa), which is increasingly used as a nonrodent species in Chapter 7. Hepatobiliary System nonclinical toxicology studies. The different breeds of minipigs Chapter 8. Integumentary System used in the field of nonclinical safety assessment include the Chapter 9. Mammary Gland Go¨ttingen, Hanford, Yucatan, Wuzhishan, and Sinclair mini- Chapter 10. Nervous System pig, with the Go¨ttingen as the most commonly used breed in Chapter 11. Reproductive System—Female North America, Japan, and Europe. The nomenclature, obser- Chapter 12. Reproductive System—Male vations, and comments included in this article cover all these Chapter 13. Respiratory System breeds, but most data are derived from the Go¨ttingen minipig. Chapter 14. Skeletal System The focus of the present publication is on standardized terms Chapter 15. Soft Tissue and diagnostic criteria for histopathology findings that occur in Chapter 16. Special Senses nonclinical safety studies conducted in the minipig and will not Chapter 17. Urinary System include all background lesions of domestic pigs. References to Figure Legends domestic pigs have been included, where appropriate. References Throughout this publication, findings applicable for use in gen- eral toxicology studies in minipigs are tabulated by organ sys- tem. The nomenclature and tables in this publication build on Chapter 1. Introduction the existing INHAND rodent nomenclature. In most instances, The INHAND Project (International Harmonization of Nomen- the definition and description of the rodent lesion applies to the clature and Diagnostic Criteria) is a joint initiative of the soci- minipig and is not described further. This publication focuses eties of toxicologic pathology from Europe (European Society on findings that are unique to the minipig and are not observed of Toxicologic Pathology [ESTP]), United Kingdom (British in rodents, findings in the minipigs that share the same termi- Society of Toxicological Pathologists [BSTP]), Japan (Japa- nology with a rodent finding but display different morphologic nese Society of Toxicologic Pathology [JSTP]), and North features, or findings for which additional commentary specific America (Society of Toxicologic Pathology [STP]) to update to the minipig is needed. Findings that are unique to rats or the existing World Health Organization/International Agency mice and are not found in minipigs are denoted accordingly in for Research on Cancer (WHO/IARC) and Society of Toxico- the tables in this article. The tabulated findings are categorized logic Pathology/Standardized System of Nomenclature and accordingtothefollowingcharacteristics: “common,” Diagnostic Criteria (STP/SSNDC) nomenclature systems. The “uncommon,” “not observed but potentially relevant,” and “not INHAND nomenclature and the related diagnostic criteria rep- applicable.” The distinction between common and uncommon resent a consensus of experienced toxicologic pathologists and findings is based on the authors’ experience regarding the were reviewed by the INHAND-Global Editorial and Steering occurrence in untreated minipigs and, when available, pub- Committee (INHAND-GESC) for compliance with INHAND lished references are included. The uncommon category is principles. Members of the societies of toxicologic pathology had reserved for changes only observed sporadically as sponta- the opportunity to comment on the draft versions of INHAND neous findings in minipig studies or those that are almost exclu- documents during a 60-day review period. The initial series of sively induced by xenobiotics. “Not observed but potentially nomenclature publications was focused on lesions in rats and relevant” are changes that have not been described or observed mice. With interest of the United States Food and Drug Admin- in minipigs; however, the use of these terms has been consid- istration (FDA) in the use of published terminology standards and ered permissible should a lesion meet the diagnostic criteria. the decision of the Clinical Data Interchange Standards Consor- The category “not applicable” refers to rodent-specific findings tium (CDISC) initiative on Standard for the Exchange of Non- and terms, and the use of these terms in minipigs is considered clinical Data (SEND) to model the controlled terminology (CT) inappropriate; examples include chronic progressive nephropa- based on the INHAND nomenclature, the INHAND project was thy of the kidney or fibro-osseous lesion of bones. It should be extended to other laboratory animal species including the nonhu- noted that minipigs used in toxicologic studies are usually man primate, rabbit, minipig, dog, and fish. young in age and are kept on study only for a relatively short Although the INHAND nomenclature and diagnostic criteria time frame, a fraction of the normal life span of the minipig. represent a preferred international standard nomenclature for Prior to study initiation, the health status of individual minipigs lesions identified in nonclinical studies, recommendations for is usually carefully checked and the individual minipigs diagnostic criteria and preferred terminology may not be appli- selected for a study are in good health. For these reasons, the cable in all situations. The purpose of specific experiments or the spectrum and frequency of changes are different from those 112 Toxicologic Pathology 49(1) encountered in domestic pigs and diagnostic laboratories, and cardiovascular system, gastrointestinal tract, and kidney. In the common age-related findings including neoplasms are rare. introduction to each of the following organ systems, a short Neoplasms described in this publication are limited to those description of, or reference to, any specific features of the observed by the authors or described in the literature. When- system that can potentially contribute to risk assessment is ever possible, the equivalent rodent term/SEND terminology
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