全部文献期刊学位论文会议报纸专利标准年鉴图书|学者科研项目
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作者:Filippos Kesisoglou , Talia Flanagan ...
来源:[J].The AAPS Journal(IF 4.386), 2017, Vol.19 (6), pp.1537-1549Springer
摘要:This manuscript represents the perspective of the Dissolution Analytical Working Group of the IQ Consortium. The intent of this manuscript is to highlight the challenges of, and to provide a recommendation on, the development of clinically relevant dissolution specifications (CRS...
作者:Filippos Kesisoglou , Mehran Yazdanian
来源:[J].The AAPS Journal(IF 4.386), 2017, Vol.19 (4), pp.989-1001Springer
摘要:The introduction of the biopharmaceutics drug classification system (Biopharmaceutics Classification System (BCS)), in 1995, provided a simple way to describe the biopharmaceutics behavior of a drug. Solubility and permeability are among the major parameters, which determine...
作者:... Dorothy Levorse , Kendra Galipeau , Filippos Kesisoglou
来源:[J].AAPS PharmSciTech(IF 1.584), 2017, Vol.18 (4), pp.1408-1416Springer
摘要:Despite many documented differences in gut physiology compared to humans, the beagle dog has been successfully used as a preclinical model for assessing the relative bioavailability of dosage forms during formulation development. However, differences in pH and bile salt concentra...
作者:Filippos Kesisoglou , Maria Vertzoni , Christos Reppas
来源:[J].AAPS PharmSciTech(IF 1.584), 2018, Vol.19 (7), pp.2851-2858Springer
摘要:Abstract(#br)Physiologically based absorption modeling has been attracting increased attention to study the interactions of weakly basic drug compounds with acid-reducing agents like proton-pump inhibitors and H2 blockers. Recently, standardized gastric and intestinal biorel...
作者:Filippos Kesisoglou , Xavier Pepin
来源:[J].The AAPS Journal(IF 4.386), 2018, Vol.20 (3), pp.1-8Springer
摘要:Abstract(#br)On May 15th–17th, 2017, the US FDA and the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) held a workshop at the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (M-CERSI), to discuss the ...
作者:Filippos Kesisoglou , Amitava Mitra
来源:[J].The AAPS Journal(IF 4.386), 2015, Vol.17 (5), pp.1224-1236Springer
摘要:Abstract(#br)Physiologically based absorption models can be an important tool in understanding product performance and hence implementation of Quality by Design (QbD) in drug product development. In this report, we show several case studies to demonstrate the potential appli...
作者:Filippos Kesisoglou , Binfeng Xia , Nancy G. B. Agrawal
来源:[J].The AAPS Journal(IF 4.386), 2015, Vol.17 (6), pp.1492-1500Springer
摘要:Abstract(#br) In vitro – in vivo correlations (IVIVC) are predictive mathematical models describing the relationship between dissolution and plasma concentration for a given drug compound. The traditional deconvolution/convolution-based approach is the most common methodolog...
作者:Filippos Kesisoglou
来源:[J].AAPS PharmSciTech(IF 1.584), 2014, Vol.15 (1), pp.20-28Springer
摘要:Abstract(#br)Formulation changes are common during drug development either due to clinical or manufacturing considerations. These changes especially at later stages of drug development oftentimes raise questions on the potential impact of a new formulation on bioavailability. In ...
作者:Filippos Kesisoglou , Mansoor Khan ...
来源:[J].The AAPS Journal(IF 4.386), 2015, Vol.17 (4), pp.1011-1018Springer
摘要:Abstract(#br)On September 16 and 17, 2014, the Food and Drug Administration (FDA) and Product Quality Research Institute (PQRI) inaugurated their Conference on Evolving Product Quality. The Conference is conceived as an annual forum in which scientists from regulatory agenci...

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