Developing Clinically Relevant Dissolution Specifications for Oral Drug Products-Industrial and Regulatory Perspectives.

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第一作者： Mark,McAllister

第一单位： Pfizer PGRD, Sandwich CT13 9NJ, UK.

作者： Mark,McAllister ^[1] ; Talia,Flanagan ^[2] ; Karin,Boon ^[3] ; Xavier,Pepin ^[4] ; Christophe,Tistaert ^[2] ; Masoud,Jamei ^[5] ; Andreas,Abend ^[6] ; Evangelos,Kotzagiorgis ^[7] ; Claire,Mackie ^[8]

作者单位： Pfizer PGRD, Sandwich CT13 9NJ, UK. ^[1] AstraZeneca UK Limited, Macclesfield SK10 2NA, UK. ^[2] UCB Pharma SA, 1420 Braine l'Alleud, Belgium. ^[3] Licensing Division, MHRA, London E14 4PU, UK. ^[4] Janssen Research and Development, 2340 Beerse, Belgium. ^[5] Certara UK, Simcyp Division, Sheffield S1 2BJ, UK. ^[6] Merck & Co., Inc., West Point, PA 19486, USA. ^[7] European Medicines Agency, 1083 HS Amsterdam, The Netherlands. ^[8]

关键词 PBBM biorelevant dissolution clinically relevant dissolution specifications drug products oral product performance

DOI 10.3390/pharmaceutics12010019

PMID 31878006

发布时间 2020-09-28

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