GLP英文全称为“GoodLnboratoryPrACtiCEforNon—clinicalIABoratoryStudies”或“Non-clinicalGoodIABoratoryPrACtiCE”即《药物非临床研究质量管理规范》。GLP的制定目的是为了提高药物非临床研究质量确保试验资料的真实性、完整性和可靠性保证人们用药安全。GLP适用于申请药品注册而进行的非临床安全性研究。GCP英文全称为“Good...
解析 是指《药物非临床研究质量管理规范》(GoodLaboratoryPracticeforNon-clinicalLaboratoryStudies,GLP),自1999年11月1日起试行。2003年6月重新发布,并于2003年9月正式实施。反馈 收藏
(一)非临床研究质量管理规范(Good Laboratory Practice for non-clinical laboratory studies,简称GLP),系指有关非临床研究机构运行管理和非临床研究项目实施的质量管理体系。 (一)非临床研究,系指为评价药物安全性,在实验室条件下,用实验系统进行的各种毒性试验,包括单次给药的毒性试验、反复给药的毒性试验、生殖毒性...
It should be noted that because animal studies are performed before and also during clinical studies, the term non-clinical is generally preferable to preclinical when discussing the full spectrum of in vitro and non-human in vivo tests associated with drug d...
Good Laboratory Practices (GLP) are critical to ensuring the quality & integrity of non-clinical studies. Learn when & why GLP is required.
Good Laboratory Practices (GLP) refers to a system where non-clinical health and safety studies are carried out, planned, monitored, recorded, archived and reported. Between 1979 and 1980, the Organization for Economic Co-Operation and Development (OECD) member countries harmonized legislation to ...
Key words:drug reaschnon-clinical laboratory studiesdrug safety evaluationevaluation quality 药物非临床研究质量管理规范(GLP)机构的正常运行,人员不仅是GLP机构不可或缺的重要因素,更是其发展之本。人员不仅要满足数量要求,更要结合工作岗位切实具备相应的能力。现行《药物非临床研究质量管理规范》组织机构和人员一章...
美国是国际上第一个对医疗器械进行立法管理的国家,与医疗器械临床前研究有关的是《美国联邦法规》(Code of Federal Regulations),21CFRpart 58,Good Laboratory Practice for Non clinical Laboratory Studies即关于临床前评价质量管理规范的相关条款,这部分内容主要规定了医疗器械在进行临床前评价时应遵守的良好实验室管理...
Non-clinicalsafetystudiesthatsupportapplicationsformarketingpermitsforproductsregulatedbytheFDA GLPregulationsdonotapplyto: Basicexploratorystudies Humanclinicalstudies Teststodeterminephysicalorchemicalcharacteristicsofacompound USGLPRegulation FDA:21CFRPart58 Fundamentalpoint/concepts GLPregulationsfocusontheprocessesthatens...
[93] Cannon, B., Nedergaard, J. 2011. Nonshivering thermogenesis and its adequate measurement in metabolic studies. J Exp Biol 214:242-253. [94] Morrison, S.F., Madden, C.J., Tupone, D. 2014. Central neural regulation of brown adipose tissue thermogenesis and energy expenditure. Cell ...