生物制药分类系统
溶解试验
药品
溶解
药理学
生物制药
渗透
化学
生化工程
医学
工程类
体外
有机化学
生物化学
生药学
生物活性
膜
作者
Kimberly Raines,Payal Agarwal,Patrick Augustijns,Alaadin Alayoubi,Lucas Attia,Annette Bauer‐Brandl,Martin Brandl,Parnali Chatterjee,Hansong Chen,Yuly Chiang Yu,Carrie A. Coutant,Ana Luisa Coutinho,David Curran,Jennifer Dressman,Bryan Ericksen,Leah W. Falade,Yi Gao,Zongming Gao,Debasis Ghosh,Tapash K. Ghosh
出处
期刊:Aaps Journal
[Springer Nature]
日期:2023-11-07
卷期号:25 (6): 103-103
被引量:18
标识
DOI:10.1208/s12248-023-00865-8
摘要
The in-person workshop "Drug Dissolution in Oral Drug Absorption" was held on May 23-24, 2023, in Baltimore, MD, USA. The workshop was organized into lectures and breakout sessions. Three common topics that were re-visited by various lecturers were amorphous solid dispersions (ASDs), dissolution/permeation interplay, and in vitro methods to predict in vivo biopharmaceutics performance and risk. Topics that repeatedly surfaced across breakout sessions were the following: (1) meaning and assessment of "dissolved drug," particularly of poorly water soluble drug in colloidal environments (e.g., fed conditions, ASDs); (2) potential limitations of a test that employs sink conditions for a poorly water soluble drug; (3) non-compendial methods (e.g., two-stage or multi-stage method, dissolution/permeation methods); (4) non-compendial conditions (e.g., apex vessels, non-sink conditions); and (5) potential benefit of having both a quality control method for batch release and a biopredictive/biorelevant method for biowaiver or bridging scenarios. An identified obstacle to non-compendial methods is the uncertainty of global regulatory acceptance of such methods.
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