International Harmonization of Nomenclature and Diagnostic Criteria (INHAND) progress to date and future plans

Abstract

The INHAND Proposal (International Harmonization of Nomenclature and Diagnostic Criteria for Lesions in Rats and Mice) has been operational since 2005. A Global Editorial Steering Committee (GESC) manages the overall objectives of the project and the development of harmonized terminology for each organ system is the responsibility of the Organ Working Groups (OWG), drawing upon experts from North America, Europe and Japan.Great progress has been made with 9 systems published to date – Respiratory, Hepatobiliary, Urinary, Central/Peripheral Nervous Systems, Male Reproductive and Mammary, Zymbals, Clitoral and Preputial Glands in Toxicologic Pathology and the Integument and Soft Tissue and Female Reproductive System in the Journal of Toxicologic Pathology as supplements and on a web site – www.goreni.org. INHAND nomenclature guides offer diagnostic criteria and guidelines for recording lesions observed in rodent toxicity and carcinogenicity studies. The guides provide representative photo-micrographs of morphologic changes, information regarding pathogenesis, and key references. During 2012, INHAND GESC representatives attended meetings with representatives of the FDA Center for Drug Evaluation and Research (CDER), Clinical Data Interchange Standards Consortium (CDISC), and the National Cancer Institute (NCI) Enterprise Vocabulary Services (EVS) to begin incorporation of INHAND terminology as preferred terminology for SEND (Standard for Exchange of Nonclinical Data) submissions to the FDA. The interest in utilizing the INHAND nomenclature, based on input from industry and government toxicologists as well as information technology specialists, suggests that there will be wide acceptance of this nomenclature. The purpose of this publication is to provide an update on the progress of INHAND.

<p>In vivo Bio-Distribution and Toxicity Evaluation of Polymeric and Lipid-Based Nanoparticles: A Potential Approach for Chronic Diseases Treatment</p>

“…Lesions were classified according to previously published criteria and scored according to a 5-tier severity scale: 0, absent; 1, minimal; 2, mild; 3, moderate; 4, marked. 33 Representative microphotographs were obtained using NDP.view2 software (Hamamatsu) in slides digitally scanned in the Hamamatsu NanoZoomerSQ, at 20x magnification.…”

“…Lesions were classified according to previously published criteria and scored according to a 5-tier severity scale: 0, absent; 1, minimal; 2, mild; 3, moderate; 4, marked. 33 Representative microphotographs were obtained using NDP.view2 software (Hamamatsu) in slides digitally scanned in the Hamamatsu NanoZoomerSQ, at 20x magnification. Birefringence of NPs under polarized light was used to assess their distribution and accumulation, scored according to the same 5-tier severity scale presented above.…”

The Vital Role of Pathology in Improving Reproducibility and Translational Relevance of Aging Studies in Rodents

“…2,41,64,65 The powerful multi-disciplinary datasets generated in preclinical testing are obtained through in-life and terminal metrics, consensus terminology and diagnostic criteria, lesion scoring, and data management. 32,33,64,65 Protocols and experimental designs should be standardized and well described. 8,15,52,58,67,35 Data must be appropriately collected, assessed, and interpreted by experienced professionals with formal pathology training who understand the limitations of the study design, model, and types of data sets.…”

Fundamental Concepts for Semiquantitative Tissue Scoring in Translational Research

“…Additionally, the usage of consistent diagnostic terminology for each organ system in rodents and large animals is strongly recommended. 9,21 Collaboration with experienced toxicologists and toxicological pathologists is highly encouraged before investigators plan these types of studies to ensure the current regulatory guidelines are followed. Unless specified, the remainder of the paper will focus on foundational concepts for semiquantitative scoring emphasizing nontoxicologic translational studies (Table 1).…”