2014年11月20日EMA/CHMP/CVMP/SWP/169430/2012人用药品委员会兽用药委员会共用设施生产不同药品用风险识别建立基于健康的暴露限度指南安全工作组同意草案2012.11兽用药委员会采用发放征求意见2012.11人用药委员会采用发放征求意见2012.12.13结束征求意见(意见截止期)2013.6.30兽用药委员会采用2014.9.11安全工作组采用2014.10人用药委员会采用2014.11.20生效日期2015.6.01关键词共享设备,风险识别,暴露极限,毒理学数据,残留活性物质,PDE.30ChurchillPlace●CanaryWharf●LondonE145EU●UnitedKingdomTelephone+44(0)2036606000Facsimile+44(0)2036605555Sendaquestionviaourwebsitewww.ema.europa.eu/contactAnagencyoftheEuropeanUnion©EuropeanMedicinesAgency,2014.Reproductionisauthorisedprovidedthesourceisacknowledged.GuidelineonsettinghealthbasedexposurelimitsforuseinriskidentificationinthemanufactureofdifferentmedicinalproductsinsharedfacilitiesEMA/CHMP/CVMP/SWP/169430/2012Page2/11在共享设施中生产不同药品用风险辨识建立健康暴露限度指南目录概要........................................................................................................31.介绍（背景）........................................................................................32.范围...................................................................................................33.法律依据..............................................................................................44.确定健康暴露限度...................................................................................44.1每日允许暴露量（PDE）计算...............................................................................................44.2临床数据使用.....................................................................................................................64.3其他给药途径推断..............................................................................................................65.具体注意事项........................................................................................76.PDE确定策略报告................................................................
