likezwh 2022-10-31 09:36 IP:广州
包括但不限于立项研究方案思路、药学研究过程(研究方案、处方分析、各物为分析、研究设计、正交设计、研究记录)、质量分析研究等(最好包括进度管理、项目管理、预算等)药学研究全套文件,而不单单是交给国家药品审评中心的格式,所提供文件最好是word格式。可多人中标,价格另谈,万元以上。   [更多]
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¥3000.00
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静默安然qq 2022-11-11 15:00 IP:昆明
求购复方聚乙二醇电解质散药品注册质量信息   [更多]
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¥100.00
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guowenqiqi 2022-11-15 16:47 IP:广州
质量标准/进口注册标准中需有对氨基酸和短肽类较为详细的测定方法,不限剂型(最好有较详细的色谱条件、对照品选择及质控限度)   [更多]
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¥60.00
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彭银鹤123 2022-10-27 11:46 IP:长沙
流式细胞术检测淋巴细胞亚群的分析方法验证方案   [更多]
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¥50.00
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飞飞01 2022-11-15 13:50 IP:深圳
求购磷酸西格列汀和磷酸西格列汀制剂最新的进口注册质量信息   [更多]
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¥50.00
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niurui 2022-10-27 11:49 IP:伊春
口服固体制剂(片剂)现有包装形式塑瓶,增加铝塑包装(pvdc)形式,按照指导原则中等变更求包材等同性、密封性研究资料及申报材料一套。   [更多]
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¥200.00
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lskingzctx 2022-11-09 15:15 IP:成都
设备、工艺相关资料。资料合适可议价。   [更多]
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¥200.00
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qiyan_xiao 2022-11-03 16:04 IP:广州
2,6-二甲基苯胺作为基因毒性杂质控制,它的每日最大摄入量是多少?(1.5μg/天做不到)目前找到一个雷诺嗪缓释片在澳洲申报的资料中提到2,6-二甲基苯胺的每日最大摄入量范围是20.4μg/天~110μg/天,有没有哪位大神知道这两个值的来源及推导过程,求助。原文如下:The sponsor also commissioned two nonclinical risk assessments on DMA relative to  potential exposure from ranolazine under the conditions of use. Both assessors referred to  methodologies advocated in the ICH guideline.21 The updated guideline permits the use of  compound-specific assessments (compared with. TTC-based acceptable intake of  1.5 μg/day) when sufficient carcinogenicity data exists, such that a compound-specific  acceptable intake can be extrapolated from measures of carcinogenic potency. Information  on the carcinogenicity of DMA is available from a 2 year dietary study in rats (NTP, 1990)  and is the only source of data on carcinogenic potency. The first nonclinical assessor referred to a follow-up report to the NTP report where  carcinogenic potential (TD50) was set at 20.4 mg/kg. By linear extrapolation the  acceptable lifetime daily intake was calculated as 0.41 μg/kg/day (24.5 μg/day for 60 kg  adult or 20.4 μg/day for 50 kg adult). The amount of DMA detected in 750 mg ranolazine  tablets after 24 months storage (1.6 μg/tablet or 3.2 μg/day based on average batch values  outlined above in Table 7) were at least 6.4 fold lower than the extrapolated acceptable  lifetime daily intake of 20.4 μg/day (for 50 kg adult at the MRHD). The assessor indicated  that this was an acceptable safety factor but recommended that the shelf life of Ranexa be  no more than 24 months to ensure ranolazine degradation was minimal. The second nonclinical assessor evaluated risk assessments conducted by other regulatory  bodies where acceptable daily levels of DMA ranged between 20.4 μg/day to 110 μg/day  (for 50 kg adult). The most conservative approach gave acceptable daily levels of  29 μg/day (20.4 μg/day for 50 kg adult) and was the same as that   [更多]
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guijiang 2022-08-13 13:06 IP:玉林
求购一套中成药的  糖衣片改为薄膜衣片的申报资料模板再好比如穿心莲片   消炎利胆片之类的   [更多]
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¥100.00
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nongzr123456 2022-08-12 15:18 IP:广州
求购利伐沙班干混悬剂质量信息(J..X..,清晰电子版   [更多]
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¥50.00
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