Towards knowledge-driven cross-species extrapolation
作者： Christoph Thiel , Ute Hofmann , Ahmed Ghallab , Rolf Gebhardt , Jan G. Hengstler
DOI: 10.1016/J.DDMOD.2017.02.008
关键词:
摘要: The transition from preclinical research to clinical phases is a crucial step in pharmaceutical development. In phase I, new molecular entity for the first administered humans, after year-long development vitro and animal models. However, significant number of projects closed during such first-in-man trials, mostly due reasons toxicity. This requires approaches through computational modelling selection explanatory models, respectively, order support phases. this review we will discuss basic challenges cross-species extrapolation before presenting some recent developments field as well future perspectives.
sci-hub.se 参考文章(20)
Michael Block, Physiologically based pharmacokinetic and pharmacodynamic modeling in cancer drug development: status, potential and gaps Expert Opinion on Drug Metabolism & Toxicology. ,vol. 11, pp. 743- 756 ,(2015) , 10.1517/17425255.2015.1037276
David Cook, Dearg Brown, Robert Alexander, Ruth March, Paul Morgan, Gemma Satterthwaite, Menelas N. Pangalos, Lessons learned from the fate of AstraZeneca's drug pipeline: a five-dimensional framework Nature Reviews Drug Discovery. ,vol. 13, pp. 419- 431 ,(2014) , 10.1038/NRD4309
F.H. Sobels, Models and assumptions underlying genetic risk assessment. Mutation Research. ,vol. 212, pp. 77- 89 ,(1989) , 10.1016/0027-5107(89)90024-9
Michael P. Snyder, Shin Lin, Yiing Lin, Joseph R. Nery, Mark A. Urich, Alessandra Breschi, Carrie A. Davis, Alexander Dobin, Christopher Zaleski, Michael A. Beer, William C. Chapman, Thomas R. Gingeras, Joseph R. Ecker, Comparison of the transcriptional landscapes between human and mouse tissues Proceedings of the National Academy of Sciences of the United States of America. ,vol. 111, pp. 17224- 17229 ,(2014) , 10.1073/PNAS.1413624111
Antonello Caruso, Nicolas Frances, Christophe Meille, Andrea Greiter-Wilke, Alexander Hillebrecht, Thierry Lavé, Translational PK/PD modeling for cardiovascular safety assessment of drug candidates: Methods and examples in drug development. Journal of Pharmacological and Toxicological Methods. ,vol. 70, pp. 73- 85 ,(2014) , 10.1016/J.VASCN.2014.05.004
Anne E. Loccisano, Jerry L. Campbell, Melvin E. Andersen, Harvey J. Clewell, Evaluation and prediction of pharmacokinetics of PFOA and PFOS in the monkey and human using a PBPK model Regulatory Toxicology and Pharmacology. ,vol. 59, pp. 157- 175 ,(2011) , 10.1016/J.YRTPH.2010.12.004
Torka S. Poet, Betsy D. Carlton, James A. Deyo, Paul M. Hinderliter, Hydroquinone PBPK model refinement and application to dermal exposure. Food and Chemical Toxicology. ,vol. 48, pp. 3085- 3092 ,(2010) , 10.1016/J.FCT.2010.08.002
Freimut Schliess, Stefan Hoehme, Sebastian G. Henkel, Ahmed Ghallab, Dominik Driesch, Jan Böttger, Reinhard Guthke, Michael Pfaff, Jan G. Hengstler, Rolf Gebhardt, Dieter Häussinger, Dirk Drasdo, Sebastian Zellmer, Integrated metabolic spatial-temporal model for the prediction of ammonia detoxification during liver damage and regeneration Hepatology. ,vol. 60, pp. 2040- 2051 ,(2014) , 10.1002/HEP.27136
Christoph Thiel, Sebastian Schneckener, Markus Krauss, Ahmed Ghallab, Ute Hofmann, Tobias Kanacher, Sebastian Zellmer, Rolf Gebhardt, Jan G. Hengstler, Lars Kuepfer, A systematic evaluation of the use of physiologically based pharmacokinetic modeling for cross-species extrapolation. Journal of Pharmaceutical Sciences. ,vol. 104, pp. 191- 206 ,(2015) , 10.1002/JPS.24214
Paul Morgan, Piet H. Van Der Graaf, John Arrowsmith, Doug E. Feltner, Kira S. Drummond, Craig D. Wegner, Steve D.A. Street, Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival. Drug Discovery Today. ,vol. 17, pp. 419- 424 ,(2012) , 10.1016/J.DRUDIS.2011.12.020