Basic principles of non-clinical development

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1. In silico, in vitro, and in vivo studies

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There are three different ways to do non-clinical studies:

  1. ‘In silico’ which means that the study is done on a computer or via computer simulation, e.g. to predict how toxic the medicinal product is based on its chemical structure.
  2. ‘In vitro’ (Latin for ‘within the glass’) which means that the study is done outside of a living organism and under control, e.g. by use of hepatocyte (cells from the liver) cultures for metabolism studies.
  3. 'In vivo’ (Latin for ‘within the living’) which means that the study is carried out using a whole, living organism in stead of tissues or cells, i.e. animals, humans or plants.