Harmonization of Lesion Nomenclature in Laboratory Animals
The goal of this chapter is to provide consensus for the harmonization of preclinical terminology for ultimate adoption on studies submitted to US Food and Drug Administration (FDA) and other global regulatory agencies. Included is a list of descriptive-based terminology for anatomical subsections of the eye with associated definitions and synonyms. We are recommending use of this harmonized terminology for description of common lesions observed spontaneously or associated with test article-induced changes. The tables provided contain listings for all necessary base-root lesions, while recommended modifiers are addressed in the section text. Additionally, there are representative images for selected lesions to provide the reader specific examples of the ocular changes they may encounter on ophthalmology examinations.
KeywordsTerminology Ocular lesions Laboratory animal Ocular toxicology Harmonization
The authors wish to thank Drs. David Wilkie, Roy Bellhorn, and Randy Sharp for generously providing images, Dr. Craig Zwickle (Chair SEND CT) for a detail discussion regarding the SEND terminology approval process, and Dr. John Vahle (Member INHAND GESC) for providing a historical perspective of the INHAND effort.
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