Young Jamie K, Hall Robert L, O'Brien Peter, Strauss Volker, Vahle John L
Covance Laboratories, Greenfield, Indiana, USA.
Toxicol Pathol. 2011 Feb;39(2):429-34. doi: 10.1177/0192623310396512. Epub 2011 Feb 4.
The Society of Toxicologic Pathology (STP) and American Society for Veterinary Clinical Pathology (ASCVP) convened a Clinical Pathology in Carcinogenicity Studies Working Group to recommend best practices for inclusion of clinical pathology testing in carcinogenicity studies. Regulatory guidance documents and literature were reviewed, and veterinary pathologists from North America, Japan, and Europe were surveyed regarding current practices, perceived value, and recommendations for clinical pathology testing in carcinogenicity studies. For two-year rodent carcinogenicity studies, the Working Group recommends that clinical pathology testing be limited to collection of blood smears at scheduled and unscheduled sacrifices to be examined only if indicated to aid in the diagnosis of possible hematopoietic neoplasia following histopathologic evaluation. Additional clinical pathology testing is most appropriately used to address specific issues from prior toxicity studies or known test article-related class effects. Inadequate data were available to make a recommendation concerning clinical pathology testing for alternative six-month carcinogenicity assays using genetically modified mice, although the Working Group suggests that it may be appropriate to use the same approach as for two-year carcinogenicity studies since the study goal is the same.
毒理病理学会（STP）和美国兽医临床病理学会（ASCVP）召集了一个致癌性研究中的临床病理学工作组，以推荐在致癌性研究中纳入临床病理学检测的最佳实践方法。对监管指南文件和文献进行了审查，并就致癌性研究中临床病理学检测的当前实践、感知价值和建议，对来自北美、日本和欧洲的兽医病理学家进行了调查。对于两年期啮齿动物致癌性研究，工作组建议临床病理学检测仅限于在定期和不定期处死时采集血涂片，仅在组织病理学评估后提示有助于诊断可能的造血系统肿瘤时才进行检查。额外的临床病理学检测最适合用于解决先前毒性研究中的特定问题或已知的受试物相关类效应。关于使用基因改造小鼠进行的替代六个月致癌性试验的临床病理学检测，由于缺乏足够的数据来提出建议，尽管工作组建议鉴于研究目标相同，可能适合采用与两年期致癌性研究相同的方法。
