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Biosimulation in Drug Development

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Drug development is far from a straightforward endeavor. It starts with the identification of a pharmaceutically promising substance, the potential of which is further investigated in near-exhausting physiological analyses (Chapter 1). If it is found effective, this does not necessarily mean that we know all the molecular consequences when administered. Each patient is an individual, with unique features, which may mean patient treatment at the level of the individual; so-called personal medicine. This illustrates the complexity of drug development and discovery.

Does it get any simpler when we consider the physiological and molecular events upon drug ingestion? A perorally administered drug first of all enters the gastrointestinal tract where it encounters the biotransformatory activity of the intestinal microflora. Our knowledge of which compounds finally enter the blood stream is fragmentary at best, not to mention the interactions of the drug with the different organs and the resulting organ–organ interplays (Chapter 3). And this is not the only question arising. How do drugs interact with human physiology? Whether we can simulate drug effects then becomes very important (Chapters 6 and 8). Further, how do the organs interact with each other upon the ingestion of a drug? Can we achieve a whole-body simulation? Or virtual populations? Can we, and to what extent, treat individuality and gender in drug administration? What advantages lie behind technologies that can simulate drug action and effect (Chapters 11 and 14)? If we can do all this, how can we use these simulations to our advantage in drug discovery and development? To what are undesired side-effects attributable? What do we know of drug–drug interactions, drug–drug metabolite interactions, and their outcomes on organs or on the interplay between different organs? Can we, by applying novel methodologies, shorten package inserts, even make them superfluous?

This first comprehensive survey to cover all pharmaceutically relevant topics provides a comprehensive introduction to this novel and revolutionary tool, presenting both concepts and application examples of biosimulated cells, organs and organisms.

Following an introduction to the role of biosimulation in drug development, the authors go on to discuss the simulation of cells and tissues, as well as simulating drug action and effect. A further section is devoted to simulating networks and populations, and the whole is rounded off by a look at the potential for biosimulation in industrial drug development and for regulatory decisions.

Part of the authors are members of the BioSim Network of Excellence that encompasses more than 40 academic institutions, pharmaceutical companies and regulatory authorities dealing with drug development; other contributors come from industry, resulting in a cross-disciplinary expert reference.

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