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      The Simcyp Population Based Simulator: Architecture, Implementation, and Quality Assurance

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          Abstract

          Developing a user-friendly platform that can handle a vast number of complex physiologically based pharmacokinetic and pharmacodynamic (PBPK/PD) models both for conventional small molecules and larger biologic drugs is a substantial challenge. Over the last decade the Simcyp Population Based Simulator has gained popularity in major pharmaceutical companies (70% of top 40 - in term of R&D spending). Under the Simcyp Consortium guidance, it has evolved from a simple drug-drug interaction tool to a sophisticated and comprehensive Model Based Drug Development (MBDD) platform that covers a broad range of applications spanning from early drug discovery to late drug development. This article provides an update on the latest architectural and implementation developments within the Simulator. Interconnection between peripheral modules, the dynamic model building process and compound and population data handling are all described. The Simcyp Data Management (SDM) system, which contains the system and drug databases, can help with implementing quality standards by seamless integration and tracking of any changes. This also helps with internal approval procedures, validation and auto-testing of the new implemented models and algorithms, an area of high interest to regulatory bodies.

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          Most cited references23

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          Genetic Algorithms in Search, Optimization, and Machine Learning

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            • Article: not found

            A modification of receptor theory.

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              • Record: found
              • Abstract: not found
              • Article: not found

              Iterative and incremental developments. a brief history

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                Author and article information

                Contributors
                m.jamei@simcyp.com
                s.marciniak@simcyp.com
                d.edwards@simcyp.com
                k.wragg@simcyp.com
                k.feng@simcyp.com
                a.barnett@simcyp.com
                amin.rostami@manchester.ac.uk
                Journal
                In Silico Pharmacol
                In Silico Pharmacol
                In Silico Pharmacology
                Springer-Verlag (Berlin/Heidelberg )
                2193-9616
                3 June 2013
                3 June 2013
                2013
                : 1
                Affiliations
                [ ]Simcyp Limited (a Certara Company), Blades Enterprise Centre, John Street, Sheffield, S2 4SU UK
                [ ]Centre of Applied Pharmacokinetic Research, the School of Pharmacy and Pharmaceutical Sciences, the University of Manchester, Manchester, UK
                Article
                9
                10.1186/2193-9616-1-9
                4230310
                25505654
                2ebc72ea-d74e-4bed-99ca-e8e3913edc11
                © Jamei et al.; licensee Springer. 2013

                This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                Categories
                Original Research
                Custom metadata
                © The Author(s) 2013

                adme,pharmacokinetics,pharmacodynamics,physiologically-based pharmacokinetic,simcyp,model based drug development

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