特立帕肽注射液人体等效性研究现状分析及相关考虑( 四 )


五、参考文献
[1]《中国骨质疏松症流行病学调查报告2018.》
[2]特立帕肽注射液(复泰奥?)中文说明书.
[3]特立帕肽注射液(フォルテオ?皮下注キット600μg)日本IF文件.
[4]特立帕肽注射液生物类似药临床试验设计指导原则》.
[5]livogiva-epar-public-assessment-report_en.EMA
[6]FORTEO(teriparatideinjection),forsubcutaneoususe.FDAlable.
[7]movymia-epar-public-assessment-report_en
[8]sondelbay-epar-public-assessment-report_en.EMA
[9]Farías,J.,Keller,G.A.,Papouchado,M.,VillaEtchegoyen,M.C.,Criscuolo,M.E.,Diez,R.A.,&DiGirolamo,G.(2016).Relativebioavailabilitybetweentwoteriparatideformulationsinhealthyvolunteers.Internationaljournalofclinicalpharmacologyandtherapeutics,54(8),649–656.
[10]Takács,I.,Jókai,E.,Kováts,D.E.,&Aradi,I.(2019).Thefirstbiosimilarapprovedforthetreatmentofosteoporosis:resultsofacomparativepharmacokinetic/pharmacodynamicstudy.Osteoporosisinternational:ajournalestablishedasresultofcooperationbetweentheEuropeanFoundationforOsteoporosisandtheNationalOsteoporosisFoundationoftheUSA,30(3),675–683.
[11]特立帕肽注射液(CXSS2100011)申请上市技术审评报告.返回搜狐 , 查看更多
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