《(医疗药品管理)某市协和建昊医药技术开发有限责任公司精品》由会员分享，可在线阅读，更多相关《(医疗药品管理)某市协和建昊医药技术开发有限责任公司精品（7页珍藏版）》请在金锄头文库上搜索。
1、北京协和建昊医药技术开发有限责任公司Beijing Uuion-Genius Pharmaceutical Technology Ltd 项目领域Testing field序号No.项目名称Name of study方法号Method codeOECD编号OECD code所需样品量（克）Needed sample(g)所需时间（天）Needed Time(d)健康毒理Health Effects1急性经口毒性试验Acute Oral Toxicity Test4014012030282急性经皮毒性试验Acute Dermal Toxicity Test4024021020283急性吸入毒性试
2、验Acute Inhalation Toxicity Test4034032030284急性皮肤刺激性/腐蚀性试验Acute Dermal Irritation/Corrosion Test4044041020285急性眼刺激性/腐蚀性试验Acute Eye Irritation/Corrosion Test4054051020286皮肤致敏试验Skin Sensitization Test4064062030407啮齿类动物28天反复经口毒性试验Repeated Dose 28-day Oral Toxicity Study in Rodents4074076008001508啮齿类动物亚慢
3、性（90天）经口毒性试验Repeated Dose 90-day Oral Toxicity in Rodents408408100020002109非啮齿类动物亚慢性（90天）经口毒性试验Repeated Dose 90-day Oral Toxicity in Nonrodents4094092000400021010反复经皮毒性：21/28天试验Repeated Dose Dermal Toxicity:21/28-day Study41041060080015011亚慢性经皮毒性：90天试验Subchronic Dermal Toxicity: 90-day Study41141110
4、00200021012反复吸入毒性：28天或14天试验Repeated Dose Inhalation Toxicity: 28/14-day Study41241260080015013亚慢性吸入毒性：90天试验Subchronic Inhalation Toxicity: 90-day Study4134131000200021014致畸试验Teratogenicity41441450080012015一代繁殖毒性试验One-Generation Reproduction Toxicity Study4154151000200018016两代繁殖毒性试验Two- Generation Re
5、production Toxicity Study4164161000200024017毒物动力学试验Toxicokinetics Study41741720040012018有机磷化合物急性染毒的迟发性神经毒性试验Delayed Neurotoxicity of Organophosphorus Substances Following Acute Exposure41841830409019有机磷化合物亚慢性（28天）染毒的迟发性神经毒性实验Delayed Neurotoxicity of Orgarophosphorus Substances: 28-day Repeated Dose
6、Method41941920040015020急性经口毒性：固定剂量法Acute Oral Toxicity-Fixed Dose Method42042020402821生殖和发育毒性筛选试验Reproduction/Developmental Toxicity Screening Test42142130050015022结合反复染毒毒性研究的生殖发育毒性筛选试验Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test42242250080021023急
7、性经口毒性：急性毒性的阶层法Acute Oral Toxicity-Acute Toxic Class Method42342350604024啮齿类动物的神经毒性试验Neurotoxicity Study in Rodents4244243005009025急性经口毒性：上下增减剂量法Acute Oral Toxicity: Up and Down Procedure42542550604026致癌试验Carcinogenicity Studies4514515000800072027慢性毒性试验Chronic Toxicity Studies4524523000600036028慢性毒性与
8、致癌性联合试验Combined Chronic Toxicity/Carcinogenicity Studies4534535000800072029细菌回复突变试验Bacterial Reverse Mutation Test471， 472471， 47210206030体外哺乳动物细胞染色体畸变试验In vitro Mammalian Chromosome Aberration Test47347310206031哺乳动物红细胞微核试验Mammalian Erythocyte Micronucleus Test47447430503532哺乳动物骨髓染色体畸变试验Mammalian Bo
9、ne Marrow Chromosome Aberration Test47547510206033体外哺乳动物细胞基因突变试验In vitro Mammalian Cell Gene Mutation Test47647610209034黑腹果蝇伴性隐性致死试验Sex-linked Recessive Lethal Test in Drosophila Melanogaster, SLRL47747710209035啮齿类动物显性致死试验Rodent Dominant Lethal Test4784782004009036哺乳类动物细胞姐妹染色单体互换体外试验In vitro Sister
10、Chromatid Exchange Assay in Mammalian Cells47947910209037酿酒酵母基因突变试验Saccharomyces cerevisiae, Gene Mutation Assay48048010206038酿酒酵母有丝分裂重组试验Saccharomyces Cerevisiae Mitotic Recombination Assay48148110206039哺乳类动物细胞DNA损害与修复/程序外DNA合成体外试验DNA Damage and Repair/Unscheduled DNA Synthesis in Mammalian Cells i
11、n vitro48248210209040哺乳动物精原细胞染色体畸变试验Mammalian Spermatogonial Chromosome Aberration Test48348310209041小鼠斑点试验Mouse Spot Test4844841002009042小鼠可遗传易位试验Mouse Heritable Translocation Assay4854852004009043体内哺乳动物肝细胞程序外DNA合成（UDS）试验Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo4864861
12、0209044空斑形成细胞试验（PFC）Plaque Forming Cell Assay49049010209045迟发型超敏反应试验Delayed Type Hypersensitivity Test4914911002009046自然杀伤细胞活性试验Natural Killer Cell Activity Assay492492102090理化性质Physical-chemical property47紫外-可见吸收光谱US-VIS Absorption Spectra10110110060 48熔点/熔点范围 Melting Point/Melting Range10210210030
13、 49沸点 Boiling Point10310320060 50蒸汽压 Vapour Pressure104104100180 51水溶解度 Water Solubility10510510090 52吸附/解析 Adsorption/Desorption10610650120 53分配系数（正辛醇/水）-摇瓶法Partition Coefficient(n-octanol/water-Polarographic Method)10710710090 54液体和固体的密度 Density of Liquids and Solids109109200ml/200g60 55颗粒物粒度分布/纤维长度和直径分布 Particle Size Distribution/Fibre Length and Diameter Distributions11011010060 56与PH有关的水解作用Hydrolysis as a Function of Ph11111150300 57分配系数（正辛醇/水）-高效液相色谱法 Partition Coefficient(n-octanol/water-HPLC Metho
