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Year of publication
- 2016 (284) (remove)
Institute
- Fachbereich Medizintechnik und Technomathematik (54)
- Fachbereich Chemie und Biotechnologie (44)
- Fachbereich Bauingenieurwesen (35)
- Fachbereich Elektrotechnik und Informationstechnik (35)
- IfB - Institut für Bioengineering (35)
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- Fachbereich Luft- und Raumfahrttechnik (28)
- Fachbereich Maschinenbau und Mechatronik (26)
- Fachbereich Energietechnik (17)
- INB - Institut für Nano- und Biotechnologien (15)
- MASKOR Institut für Mobile Autonome Systeme und Kognitive Robotik (11)
- Fachbereich Architektur (9)
- ECSM European Center for Sustainable Mobility (5)
- Institut fuer Angewandte Polymerchemie (5)
- Nowum-Energy (5)
- Solar-Institut Jülich (5)
- ZHQ - Bereich Hochschuldidaktik und Evaluation (5)
- FH Aachen (2)
- IBB - Institut für Baustoffe und Baukonstruktionen (2)
- Fachbereich Gestaltung (1)
Document Type
- Article (118)
- Conference Proceeding (81)
- Part of a Book (29)
- Book (25)
- Other (10)
- Conference: Meeting Abstract (8)
- Report (6)
- Doctoral Thesis (3)
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- Patent (1)
Keywords
- Technical Operations Research (2)
- Additive Manufacturing (1)
- Annulus Fibrosus (1)
- Archeology (1)
- Assessment (1)
- Asymptotic efficiency (1)
- Bacillus atrophaeus (1)
- Balance (1)
- Balanced hypergraph (1)
- Brandfall (1)
NVS123 is a poorly water-soluble protease 56 inhibitor in clinical development. Data from in vitro hepatocyte studies suggested that NVS123 is mainly metabolized by CYP3A4. As a consequence of limited solubility, NVS123 therapeutic plasma exposures could not be achieved even with high doses and optimized formulations. One approach to overcome NVS123 developability issues was to increase plasma exposure by coadministrating it with an inhibitor of CYP3A4 such as ritonavir. A clinical boost effect was predicted by using physiologically based pharmacokinetic (PBPK) modeling. However, initial boost predictions lacked sufficient confidence because a key parameter, fraction of drug metabolized by CYP3A4 (ƒₘCYP3A4), could not be estimated with accuracy on account of disconnects between in vitro and in vivo preclinical data. To accurately estimate ƒₘCYP3A4 in human, an in vivo boost effect study was conducted using CYP3A4-humanized mouse model which showed a 33- to 56-fold exposure boost effect. Using a top-down approach, human ƒₘCYP3A4 for NVS123 was estimated to be very high and included in the human PBPK modeling to support subsequent clinical study design. The combined use of the in vivo boost study in CYP3A4-humanized mouse model mice along with PBPK modeling accurately predicted the clinical outcome and identified a significant NVS123 exposure boost (∼42-fold increase) with ritonavir.