最新版   [更多]

詳細要求：蔗糖氫氧化氧鐵咀嚼片參比質(zhì)量信息 、工藝信息等，最好含有復核說明和老師意見。   [更多]

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

研發(fā)資料、注冊資料、同品種臨床評價資料、成功注冊過醫(yī)療器械優(yōu)先。透明質(zhì)酸鈉凝膠產(chǎn)品組成：產(chǎn)品由緩沖溶液(磷酸氫二鈉、磷酸二氫鈉、氯化鈉、 注射用水)、透明質(zhì)酸鈉組成。 預期用途：用于非慢性創(chuàng)面（如淺表性創(chuàng)面、小創(chuàng)口、擦傷 、激光/光子/果酸換膚/微整形術(shù)后創(chuàng)面）的護 理，為創(chuàng)面愈合提供微環(huán)境。醫(yī)用透明質(zhì)酸鈉 修復貼 產(chǎn)品組成：本品由透明質(zhì)酸鈉溶液和無紡布組成。透明質(zhì)酸鈉溶液 由透明質(zhì)酸鈉、甘油、卡波姆、三乙醇胺、苯氧乙醇和 純化水制成。產(chǎn)品無菌供應。預期用途：適用于非慢性創(chuàng)面（如淺表性創(chuàng)面、小創(chuàng)口、擦 傷、微整形術(shù)后創(chuàng)面）的護理，為創(chuàng)面愈合提供 微環(huán)境。醫(yī)用透明質(zhì)酸鈉 修復液 產(chǎn)品組成：本品由透明質(zhì)酸鈉溶液和包裝材料組成。透明質(zhì)酸鈉溶 液由透明質(zhì)酸鈉、甘油、卡波姆、三乙醇胺、苯氧乙醇 和純化水制成。產(chǎn)品無菌供應。 預期用途：用于小創(chuàng)口、擦傷、微整形術(shù)后創(chuàng)面、激光/光 子/果酸換膚/微整形術(shù)后創(chuàng)面等非慢性創(chuàng)面及周 圍皮膚的護理。   [更多]

關(guān)鍵參數(shù)可做刪除   [更多]

最新版   [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]

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

設備、工藝相關(guān)資料。資料合適可議價。   [更多]