Biosimulation a New Tool in Drug Development


BioSim is a Network of Excellence established by the European Commission under its 6th Framework Programme and initiated on December 1, 2004. The main objective of the Network is to demonstrate how the use of modern simulation technique can lead to: - a more rational drug development process - improved treatment procedures - a reduction in the needs for animal experiments. With its 26 academic, 10 industrial and 4 regulatory partners, the BioSim Network commands a wide range of biomedical expertise. At the same time, the network involves leading experts in pharmacokinetics, computer simulation, and complex systems theory. The purpose of the Network is to develop simulation models of genetic, cellular, physiological and pharmacological processes to provide a deeper understanding of the biological and pathological processes and help the pharmaceutical industry to develop new and more effective medicines. Biosimulation combines knowledge from a variety of disciplines such as physiology, pharmacology, cell biology, complex systems theory, and information technology. BioSim is therefore engaged in a wide range of educational activities, including the training of PhD students, specialized courses for industry and regulatory experts, and communication with the public. A simulation model describes the temporal variation of a system in terms of the processes and interactions that are presumed to be at work. In connection with the development of a drug, the model will combine a pharmacokinetic description of the absorption, distribution, metabolism, and excretion of the drug with a detailed representation of the mechanisms responsible for its function and for the development of side effects and possible synergetic interactions with other medicines. The challenge to the BioSim Network is to demonstrate that creation of simulation models can be extremely helpful in the development and approval of new medicines.

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