Best Practice in Toxicological Pathology

摘要: Abstract Toxicological pathology is a critical component of the safety assessment new drug candidates in preclinical studies. The identification, characterization, and interpretation drug-induced histopathological changes require trained pathologists technical staff who generate high-quality necropsy microscopic data communicate an integrated report including clinical organ weights. are recorded consistent manner using internationally agreed standardized nomenclature diagnostic terms grading severity lesion and, where necessary, stating distribution lesion. It role pathologist to distinguish between lesions that either spontaneous unknown cause or represent normal morphological variations tissue at different functional phases, induced by test article under assessment. In latter case, also determines adversity otherwise with study director, helps establish no-observed-adverse-effect-level (NOAEL) on weight-of-evidence basis. standardization necropsy, collection processing, use histopathology, together robust peer review, guarantee quality, consistency, integrity their interpretation. best practices strictly adhere guidelines Standard Operating Procedures (SOPs). purpose this chapter describe processes procedures toxicological necessary for generation valid results interpretation, highlight examples some common test-article-induced encountered standard toxicity Clinical parameters will be mentioned only when relevant consideration.