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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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