求助2,6-二甲基苯胺限度來源
- 發(fā)布需求
- 藥智客交稿
- 任務(wù)主選稿中
- 驗收與付款
- 交易模式：
- 單人中標
- 賞金分配：
- 一人獨享賞金，￥170
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）
目前找到一個雷諾嗪緩釋片在澳洲申報的資料中提到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 outlined by the first……
當前為付費需求，賞金分配方式：一人獨享賞金。
任務(wù)主在眾多備選稿件中選擇最滿意的稿件，支付賞金。
托管賞金，保障各方權(quán)益：
任務(wù)主把所發(fā)需求的懸賞金托管到藥智網(wǎng)指定賬戶，以激發(fā)眾多藥智客的參與熱情，保障任務(wù)主盡快征集到滿意稿件；
同時，賞金托管也是為了保障參與挑戰(zhàn)的藥智客的正當權(quán)益。
流程說明：
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任務(wù)主在眾多參與者提交的稿件中，選擇符合任務(wù)主需求的稿件。再通過互動，選擇任務(wù)主最滿意的稿件，并確定其為中標稿件。
中標稿件提交任務(wù)主驗收。任務(wù)主在驗收/驗證期內(nèi)，完成驗收/驗證工作。對合格稿件，通知藥智網(wǎng)支付傭金。
雙方可以針對本次交易各自的表現(xiàn)進行評價，評價結(jié)果將影響各自的信用度和能力值。
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