求購復(fù)方聚乙二醇電解質(zhì)散藥品注冊(cè)質(zhì)量信息   [更多]

質(zhì)量標(biāo)準(zhǔn)/進(jìn)口注冊(cè)標(biāo)準(zhǔn)中需有對(duì)氨基酸和短肽類較為詳細(xì)的測(cè)定方法，不限劑型（最好有較詳細(xì)的色譜條件、對(duì)照品選擇及質(zhì)控限度）   [更多]

流式細(xì)胞術(shù)檢測(cè)淋巴細(xì)胞亞群的分析方法驗(yàn)證方案   [更多]

求購磷酸西格列汀和磷酸西格列汀制劑最新的進(jìn)口注冊(cè)質(zhì)量信息   [更多]

口服固體制劑（片劑）現(xiàn)有包裝形式塑瓶，增加鋁塑包裝（pvdc）形式，按照指導(dǎo)原則中等變更求包材等同性、密封性研究資料及申報(bào)材料一套。   [更多]

設(shè)備、工藝相關(guān)資料。資料合適可議價(jià)。   [更多]

2,6-二甲基苯胺作為基因毒性雜質(zhì)控制，它的每日最大攝入量是多少？（1.5μg/天做不到）目前找到一個(gè)雷諾嗪緩釋片在澳洲申報(bào)的資料中提到2,6-二甲基苯胺的每日最大攝入量范圍是20.4μg/天~110μg/天，有沒有哪位大神知道這兩個(gè)值的來源及推導(dǎo)過程，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]

求購一套中成藥的  糖衣片改為薄膜衣片的申報(bào)資料模板再好比如穿心蓮片   消炎利膽片之類的   [更多]

求購利伐沙班干混懸劑質(zhì)量信息（J..X..，清晰電子版   [更多]

氨基酮戊酸丙酯皮膚體表吸收的結(jié)論報(bào)告，要求檢測(cè)機(jī)構(gòu)官方合法，報(bào)告要一式三份，有公章。檢測(cè)該產(chǎn)品不參與代謝，無藥理作用，不被吸收的報(bào)告.   [更多]