Formulation predictive dissolution (fPD) testing to advance oral drug product development: An introduction to the US FDA funded '21st Century BA/BE' project.

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作者： Bart,Hens ; Patrick D,Sinko ; Nicholas,Job ; Meagan,Dean ; Jozef,Al-Gousous ; Niloufar,Salehi ; Robert M,Ziff ; Yasuhiro,Tsume ; Marival,Bermejo ; Paulo,Paixão ; James G,Brasseur ; Alex,Yu ; Arjang,Talattof ; Gail,Benninghoff ; Peter,Langguth ; Hans,Lennernäs ; William L,Hasler ; Luca,Marciani ; Joseph,Dickens ; Kerby,Shedden ; Duxin,Sun ; Gregory E,Amidon ; Gordon L,Amidon

关键词 Bioavailability Bioequivalence Computational fluid dynamics In vivo dissolution MRI Manometry Oral absorption

主题词投药, 口服(Administration, Oral);药物调剂(Drug Compounding);人类(Humans);美国(United States);美国食品和药物管理局(United States Food and Drug Administration)

DOI 10.1016/j.ijpharm.2018.06.050

PMID 29944899

发布时间 2024-08-22

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准确一般字义偏差语意偏离译文作用小提交