求購獨(dú)家中成藥批文，有資源投稿聯(lián)系   [更多]

信息要求：1.已上市藥品；2. 藥品類型：化學(xué)藥品；3.生產(chǎn)廠家數(shù)：獨(dú)家（含劑型）。提交稿件要求：1. 提供轉(zhuǎn)讓項(xiàng)目名稱、轉(zhuǎn)讓方單位名稱、轉(zhuǎn)讓方聯(lián)系人、聯(lián)系電話信息；2. 轉(zhuǎn)讓信息真實(shí)可靠，轉(zhuǎn)讓方非第三方中介；3. 須為藥智網(wǎng)項(xiàng)目轉(zhuǎn)讓數(shù)據(jù)庫中未包含信息；4. 交稿內(nèi)容以附件形式提交；驗(yàn)收標(biāo)準(zhǔn)：按要求投遞信息后，經(jīng)我方電話驗(yàn)證信息真實(shí)無誤，即可獲取賞金。   [更多]

一類醫(yī)療器械《一次性使用引流袋》注冊(cè)資料（全套資料   [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]

混懸型乳膏劑；要全套的注冊(cè)申報(bào)資料模板（數(shù)據(jù)等需要保密的可刪）；   [更多]

如題，要求PDF版，文字清晰，能復(fù)制的最好。   [更多]

信息要求：1. 要轉(zhuǎn)讓標(biāo)的企業(yè)營(yíng)收過億元；2. 利潤(rùn)3000萬以上；3. 自有專利技術(shù)；4. 研發(fā)、生產(chǎn)、營(yíng)銷為一體的企業(yè)；提交稿件要求：1. 提供轉(zhuǎn)讓項(xiàng)目名稱、轉(zhuǎn)讓方單位名稱、轉(zhuǎn)讓方聯(lián)系人、聯(lián)系電話信息；2. 轉(zhuǎn)讓信息真實(shí)可靠，轉(zhuǎn)讓方非第三方中介；3. 交稿內(nèi)容以附件形式提交；驗(yàn)收標(biāo)準(zhǔn)：按要求投遞信息后，經(jīng)我方電話驗(yàn)證信息真實(shí)無誤，即可獲取賞金。   [更多]

信息要求：1. 要轉(zhuǎn)讓標(biāo)的企業(yè)營(yíng)收過億元；2. 利潤(rùn)3000萬以上；3. 自有專利技術(shù)；4. 研發(fā)、生產(chǎn)、營(yíng)銷為一體的企業(yè)；提交稿件要求：1. 提供轉(zhuǎn)讓項(xiàng)目名稱、轉(zhuǎn)讓方單位名稱、轉(zhuǎn)讓方聯(lián)系人、聯(lián)系電話信息；2. 轉(zhuǎn)讓信息真實(shí)可靠，轉(zhuǎn)讓方非第三方中介；3. 交稿內(nèi)容以附件形式提交；驗(yàn)收標(biāo)準(zhǔn)：按要求投遞信息后，經(jīng)我方電話驗(yàn)證信息真實(shí)無誤，即可獲取賞金。   [更多]

求購一份蒙脫石散一致性評(píng)價(jià)的申報(bào)資料用于學(xué)習(xí)   [更多]

需要一份非臨床試驗(yàn)SOP（包含項(xiàng)目管理、監(jiān)查、會(huì)議、數(shù)據(jù)管理等）、以及一份完整的非臨床研究中心的SOP（包含應(yīng)急預(yù)案），可以知道具體工作的，謝謝。   [更多]