3定义.1急性经口毒性acuteoraltoxicity.一次或在24h内多次经口给予实验动物受试物后,动物在短期内出现的健康损害效应。2经口LD50半数致死量mediumlethaldose.经口一次给予受试物后,引起实验动物总体中半数死亡的毒物的统计学剂量。以单位体重接受受试物的重量(mg/kg或g/kg)来表示。3限值剂量limitdose....
局部毒性试验 Local Toxicity Test GLP试验项目: 刺激性试验、过敏性试验、溶血性试验。 动物种属: 大鼠、豚鼠、兔、犬、猴。 给药途径: 经口(灌胃、胶囊)、静脉(推注或滴注)、肌肉注射、经皮(皮下注射、皮内注射、皮肤涂敷或喷雾)、粘膜(口腔、鼻腔、...
Developmental toxicity (embryo-fetal development); Pre- and post-natal development toxicity studies; Multigenerational studies. Regulatory toxicology studies need to be designed to detect any potential reproductive toxicology of all components contained in the vaccine including antigens, vehicles, preservative...
M.A., Isidoro, C. 2016. Dopamine exacerbates mutant Huntingtin toxicity via oxidative-mediated inhibition of autophagy in SH-SY5Y neuroblastoma cells: Beneficial effects of anti-oxidant therapeutics. Neurochem Int 101:132-143.
Single dose GLP toxicity and biodistribution study of a conditionally replicative adenovirus vector,CRAd-S-pk7,administered by intracerebral injection to Syrian hamsters. Kim J.W,Auffinger B,Spencer D.A,Miska J,Chang A.L,Kane J.R,Young J.S,Knojia D,Qiao J,Mann J.F,Zhang L,Wu M,Ahmed...
生物安全性试验 Biological Safety Test 生物相关试验:急性毒性试验(限度试验) Biological tests: Acute toxicity test (limit test) 小鼠/大鼠等 Mouse/ Rat, etc. 向日本出口时所需要做的试验(根据日本 Tests required at the time of export to Japan 法律的规格试验) (Specification tests based on the laws)...
Our toxicity tests will be performed in accordance with the OECD guidelines that are used, for example, in the REACH testing programs. We also test your food additive and nutrient sources according to the recent Guidance for submission for food additive evaluations of EFSA. In addition, we can...
药物研发的目的：•药物研发的目的：–Todevelopadrugwiththerapeuticbenefits(efficacy),andfewsideeffects(toxicity)决定药物优劣的关键性因素 质控 安全 有效 药物研究发展过程 HypothesisGeneration TargetIdentificationandValidationFirstPhasePhaseLeadOptimizationHumanIIIDosePhaseGlobalGlobalSubmitIIILaunchOptimizationQSVGoals Ca...
Key words:drug safety evaluationin vitrotoxicityalternative techniquesin vitroGLP 1959年,英国动物学家Russell和微生物学家Burch在其著作《人道实验技术原理》中首次提出了3R理论[1],即以替代(replacement)、减少(reduction)、优化(refinement)为原则。1976年,Hughes提出动物福利的概念,即人类应当合理、人道的使用动物...
Sponsors and contract research organizations conducting non-clinical safety studies on investigational new drugs must comply with U.S. law and regulations covering GLP. The FDA uses the data to answer questions regarding toxicity, adverse effects, risks, teratogenic, carcinogenic, or other adverse effec...