ljzqh1983 2021-08-22 22:21 IP:绵阳
产品为一类医疗器械  产品名称为:足部固定器   医疗器械分类目录:19-04-02需求:1、按一类医疗器械备案的要求 提供全套的备案资料;2、提供产品原辅料厂家信息;3、提供一定的技术支持。   [更多]
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gosnaly 2023-09-11 10:38 IP:上海
需要  利可君  原料药2006年标准标准号   WS-10001-(HD-0427)2002-2006   [更多]
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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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jimw0511 2021-06-10 13:52 IP:北京
东莨菪碱贴片(可弥特) 【英 文 名】 Scopolamine Patch(Kimite) 【生产厂商】 韩国 MyungMoon Pharmaceutial Co.,Ltd. 【 规 格 】 0.75mg、1.5mg 【注册证号】 H20040569、H20040570 【标 准 号】 JX20010447   [更多]
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chenmiande 2022-08-10 08:34 IP:台州
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一醉不醒ym 2021-01-19 23:33 IP:宁波
山梨醇溶液、糖精钠、枸橼酸、枸橼酸钠、羟苯甲酯、羟苯丙酯、樱桃味香精、乙二胺四乙酸二钠、诱惑红共计9种辅料的药理毒理研究内容,包含:(1)药理毒理研究资料综述。(2)对拟应用药物的药效学影响试验资料和/或文献资料。(3)非临床药代动力学试验资料和/或文献资料。(4)安全药理学的试验资料和/或文献资料。(5)单次给药毒理性的试验资料和/或文献资料。(6)重复给药毒理性的试验资料和/或文献资料。(7)过敏性(局部、全身和光敏毒性)、溶血性和局部(血管、皮肤、粘膜、肌肉等)刺激性等主要与局部、全身给药相关的特殊安全性试验研究和/或文献资料。 (8)遗传毒性试验资料和/或文献资料。(9)生殖毒性试验资料和/或文献资料。(10)致癌试验资料和/或文献资料。 (11)其他安全性试验资料和/或文献资料。   [更多]
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shifengjie 01-16 17:25 IP:未知
需要恩格列净二甲双胍缓释缓释片质量信息一份,参比制剂为synjardy,目前尚未进口至国内   [更多]
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ccn13831117235 2022-05-13 13:16 IP:石家庄
一类医疗器械《一次性使用引流袋》注册资料(全套资料   [更多]
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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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s18220376932 2023-03-01 15:57 IP:XX
混悬型乳膏剂;要全套的注册申报资料模板(数据等需要保密的可删);   [更多]
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