浅谈中国药用辅料管理现状及美国DMF药用辅料备案管理_鲁亚楠

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ChineseJournalofPharmaceuticals2016,4733631HPMCHPMCDMFSomeOpinionsonCurrentManagementofPharmaceuticalExcipientsinChinaandtheDMFExcipientRegulationsandGuidelinesintheUnitedStates*201206LUYanan,SHIHaibin,SUNNingyun*R&DCenterofSPHSinePharmaceuticalLab.,Co.,Ltd.,Shanghai201206FDADMFDMFR95C1001-8255201603-0363-04DOI10.16522/j.cnki.cjph.2016.03.0232015-10-021988Tel18617161186E-mailfightingxiaodan@126.com1981E-mailsunny773377@163.comKollicoat21CFDA31985ChineseJournalofPharmaceuticals2016,47336442201025505,63DMFFDADMFDMFFDADMF7DMFFDA8DMFDMFFDAFDADMFFDAFDA9FDADMFFDAFDAFDADMFDMFFDADMFFDAFDADMFDMFDMF10DMFDMFDMFARDMFDMFChineseJournalofPharmaceuticals2016,473365FDA11FDADMFFDADMF4DMFDMFDMFDMF12DMFDMF5200820082012201520158132016112DMFDMFDMFChineseJournalofPharmaceuticals2016,473366GMP131RobertsonM.RegulatoryissueswithexcipientsJ.IntJPharm,1999,1872:273—276.2,,,.J.,2013,7:678—681.3,,,.2010J.,2011,11:289—291.4,.J.,2007,199:131.5.EB/OL.2005-07-13.:5—7.7,.J.,2013,7:35—37.8FDA.GuidanceforIndustryNonclinicalStudiesfortheSafetyEvaluationofPharmaceuticalExcipients.EB/OL.2005-05-01.://:,2005:296—297.11FDA.21CFR314.420CEB/OL.=314.42012,.J.,2012,2113:14481492.13.EB/OL.2012-08-01.S47-27AbbasiMTetrahedronLett,2015,56:66101.10.10.56h16859650S47-28AlmeidaLSTetrahedronLett,2015,56:68430.346h105388S47-29Pd/NiLiuCTetrahedronLett,2015,56:64601Pd/Ni0.320969927.431.5

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