共用設(shè)施生產(chǎn)不同藥品用風(fēng)險(xiǎn)識(shí)別建立基于健康的暴露限度指南-全中文版-20xx628資料-資料下載頁(yè)
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【正文】 現(xiàn)有的生產(chǎn)安排需要進(jìn)行科學(xué)的證實(shí)。時(shí)間范圍： 對(duì)于人類產(chǎn)品制造商，包括人用藥物和獸用藥物共用生產(chǎn)設(shè)施的制造商，本指南發(fā)布后一年。只生產(chǎn)獸藥的制造商，本指南發(fā)布后2年。F：調(diào)整因子GMP：藥品生產(chǎn)質(zhì)量管理規(guī)范ICH：國(guó)際人用藥品注冊(cè)技術(shù)要求協(xié)調(diào)會(huì)議LOAEL：最低觀察副反應(yīng)劑量PDE：每天允許暴露值NOAEL：無(wú)明顯損害作用水平TTC：毒理學(xué)關(guān)注閾值VICH：國(guó)際動(dòng)物用藥品注冊(cè)技術(shù)要求協(xié)調(diào)會(huì)議參考: Kroes R, Renwick A, Cheeseman M, Kleiner J, Mangelsdorf I, Piersma A, Schilter B, Schatter J, van Schothorst F, Vos JG, W252。rtzen G. (2004). Structurebased thresholds of toxicological concern (TTC): guidance for application to substances present at low levels in the diet. Fd Chem Toxicol 42, 6583.Munro IC, Renwick AG, DanielewskaNikiel B (2008). The threshold of toxicological concern (TTC) in risk assessment. Toxicol Lett 180, 151156.Dolan DG, Naumann BD, Sargent EV, Maier A, Dourson M (2005). Application of the threshold of toxicological concern concept to pharmaceutical manufacturing operations. Regul Toxicol Pharmacol, 43, 19.1 Bercu JP amp。 Dolan DG, (2013). Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for shortterm clinical trials. Regul Toxicol Pharmacol. 2013 Feb。65(1):1627.Munro IC, Renwick AG, DanielewskaNikiel B (2008). The threshold of toxicological concern (TTC) in risk assessment. Toxicol Lett 180, 151156.Dolan DG, Naumann BD, Sargent EV, Maier A, Dourson M (2005). Application of the threshold of toxicological concern concept to pharmaceutical manufacturing operations. Regul Toxicol Pharmacol, 43, 19.3 Bercu JP amp。 Dolan DG, (2013). Application of the threshold of toxicological concern concept when applied to pharmaceutical manufacturing operations intended for shortterm clinical trials. Regul Toxicol Pharmacol. 2013 Feb。65(1):1627.4PDE和ADE是有效的同義詞附件PDE確定策略公司名稱公司地址專家姓名與簽字 日期評(píng)估審核日期化學(xué)名是否未知遺傳毒性生殖和發(fā)育毒性致癌性高致敏性已識(shí)別的危險(xiǎn)源 每日允許暴露量依據(jù)用于最終PDE計(jì)算的”主導(dǎo)”關(guān)鍵影響選擇的合理性NOAEL和PDE所應(yīng)用的調(diào)整因子參考用于識(shí)別關(guān)鍵組分與劑量的文獻(xiàn)專家簡(jiǎn)歷摘要內(nèi)容總結(jié)
（1）2014年11月20日
EMA/CHMP/ CVMP/ SWP/169430/2012
人用藥品委員會(huì)
獸用藥委員會(huì)
共用設(shè)施生產(chǎn)不同藥品用風(fēng)險(xiǎn)識(shí)別建立基于健康的暴露限度指
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