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临床生化指标在新药临床前研究中的毒理学意义 被引量:2

Toxicological significance of clinical biochemical indicators in preclinical studies for new drugs
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摘要 临床生化指标主要用来检测碳水化合物、脂类、蛋白质、尿液、肝胆、心血管、肌肉、胃肠道系统的代谢。临床检验的个体或汇总数据要在病理报告中分析并在实验报告中述及。阐明了临床生化指标在药物临床前研究中的毒理学和生物学意义,从而考察和反映了临床生化指标对动物机体总的代谢、营养和健康状态的影响,同时为建立和定期更新实验室各实验动物临床检验的背景值提供了参考与比较。 Clinical biochemistry indicators can be used for the test of the metabolism of carbohydrates, lipids, proteins, urine, hepatobiliary, cardiovascular, musculoskeletal, and gastrointestinal systems. Individual and summary data of clinical examination should be analyzed in the pathology report and described in the study report. This paper expounds the toxicological and biological significance of clinical biochemical indicators in drug preclinical studies, in order to study and reflect their impacts to the total metabolism, nutrition, and health status in the animal body, and to establish and termly update the background baseline of each experimental animal in CRO's clinical pathology lab for reference and comparison.
出处 《药物评价研究》 CAS 2014年第5期472-475,共4页 Drug Evaluation Research
关键词 临床生化指标 毒理学意义 临床前研究 clinical biochemical indicators toxicological significance preclinical studies
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参考文献2

  • 1L.Boone,D.Meyer,P.Cusick,D.Ennulat,A. ProvencherBolliger,N.Everds,V.Meador,G.Elliott,D.Honor,D.Bounous,H.Jordan.Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies[J].Veterinary Clinical Pathology.2008(3)
  • 2Lindsay Tomlinson,Laura I. Boone,Lila Ramaiah,Kelley A. Penraat,Barbara R. Beust,Mehrdad Ameri,Florence M. Poitout‐Belissent,Kurt Weingand,Heather C. Workman,Adam D. Aulbach,Dennis J. Meyer,Diane E. Brown,Amy L. MacNeill,Anne Provencher Bolliger,Denise I. Bounous.Best practices for veterinary toxicologic clinical pathology, with emphasis on the pharmaceutical and biotechnology industries[J].Vet Clin Pathol.2013(3)

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