Basic principles of non-clinical development
1. In silico, in vitro, and in vivo studies
There are three different ways to do non-clinical studies:
- ‘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.
- ‘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.
- '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.