Abstract:
:In therapeutic research, the safety and efficacy of pharmaceutical products are necessarily tested on humans via clinical trials after an extensive and expensive preclinical development period. Methodologies such as computer modeling and clinical trial simulation (CTS) might represent a valuable option to reduce animal and human assays. The relevance of these methods is well recognized in pharmacokinetics and pharmacodynamics from the preclinical phase to postmarketing. However, they are barely used and are poorly regarded for drug approval, despite Food and Drug Administration and European Medicines Agency recommendations. The generalization of CTS could be greatly facilitated by the availability of software for modeling biological systems, by clinical trial studies and hospital databases. Data sharing and data merging raise legal, policy and technical issues that will need to be addressed. Development of future molecules will have to use CTS for faster development and thus enable better patient management. Drug activity modeling coupled with disease modeling, optimal use of medical data and increased computing speed should allow this leap forward. The realization of CTS requires not only bioinformatics tools to allow interconnection and global integration of all clinical data but also a universal legal framework to protect the privacy of every patient. While recognizing that CTS can never replace 'real-life' trials, they should be implemented in future drug development schemes to provide quantitative support for decision-making. This in silico medicine opens the way to the P4 medicine: predictive, preventive, personalized and participatory.
journal_name
Brief Bioinformjournal_title
Briefings in bioinformaticsauthors
Gal J,Milano G,Ferrero JM,Saâda-Bouzid E,Viotti J,Chabaud S,Gougis P,Le Tourneau C,Schiappa R,Paquet A,Chamorey Edoi
10.1093/bib/bbx055subject
Has Abstractpub_date
2018-11-27 00:00:00pages
1203-1217issue
6eissn
1467-5463issn
1477-4054pii
3857769journal_volume
19pub_type
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journal_title:Briefings in bioinformatics
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pub_type: 杂志文章
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更新日期:2017-03-01 00:00:00
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journal_title:Briefings in bioinformatics
pub_type: 杂志文章
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journal_title:Briefings in bioinformatics
pub_type: 杂志文章,评审
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更新日期:2014-01-01 00:00:00
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journal_title:Briefings in bioinformatics
pub_type: 杂志文章,评审
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更新日期:2017-05-01 00:00:00
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journal_title:Briefings in bioinformatics
pub_type: 杂志文章
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journal_title:Briefings in bioinformatics
pub_type: 杂志文章
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更新日期:2010-11-01 00:00:00
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journal_title:Briefings in bioinformatics
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更新日期:2020-06-10 00:00:00
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journal_title:Briefings in bioinformatics
pub_type: 杂志文章,评审
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更新日期:2015-05-01 00:00:00
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journal_title:Briefings in bioinformatics
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更新日期:2016-09-01 00:00:00
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journal_title:Briefings in bioinformatics
pub_type: 杂志文章,评审
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更新日期:2003-03-01 00:00:00
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pub_type: 杂志文章
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