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]

1、懸賞的藥品注冊(cè)信息為2016年1月1日之后不批準(zhǔn)、退審的藥品注冊(cè)信息和補(bǔ)充藥品注冊(cè)信息 2、必須提供完整注冊(cè)信息,以附件形式提交 （以單個(gè)批件形式提交）3、核實(shí)后如果正確,每個(gè)藥品注冊(cè)信息獎(jiǎng)勵(lì)100元 4、投稿時(shí)請(qǐng)隱藏提交 5、請(qǐng)勿在百度上直接搜索 6、需是未收集的數(shù)據(jù)   [更多]

格式按照最新的《臨床評(píng)價(jià)技術(shù)指導(dǎo)原則》，按通過同品種醫(yī)療器械的臨床數(shù)據(jù)進(jìn)行臨床評(píng)價(jià)，價(jià)格可談！   [更多]

我公司中藥產(chǎn)品（劑型為顆粒劑、膠囊劑）對(duì)外合資合作，可進(jìn)行委托生產(chǎn)，也可以進(jìn)行批準(zhǔn)文號(hào)轉(zhuǎn)讓。   [更多]

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

1、全套藥物警戒體系主文件（包括目錄及具體文件），主要為管理規(guī)范類和sop類；2、符合2021年版《藥物警戒質(zhì)量管理規(guī)范》要求；3、需要有需要配套規(guī)范的文件體系名稱，藥企名稱可匿名，比如某某藥企的實(shí)際操作文件體系；4、包括但不限于：主文件、部門崗位職責(zé)、管理文件SMP 、操作文件SOP、文件管理、質(zhì)量管理、藥品安全委員會(huì)工作流程、風(fēng)險(xiǎn)管理（附風(fēng)險(xiǎn)管理計(jì)劃模板）；5、最好檢查通過的能拿過來進(jìn)行實(shí)際運(yùn)用的；   [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]

求購國內(nèi)生產(chǎn)的左氧氟沙星注射液質(zhì)量信息及說明書   [更多]