Good Simulation Practice

Good Simulation Practices

Many scientists are talking about the need for Good Simulation Practices, a term coined by the Avicenna Alliance taking inspiration from the Good Clinical Practice typical of the clinical world to bring similar rules to Modeling & Simulation applied to the Pharmaceutical and Medical Devices industries.

A Good Simulation Practices Task Force was founded at the Avicenna Alliance to ensure that the results of computer modeling and simulation (CM&S) would be universally accepted as is the case of clinical trials. There is a strong need today to have clearly defined rules and accepted regulations, since there is no document similar to that of Good Clinical Practice in the field of digital simulation. Modeling & Simulation aims to Reduce, Refine and (in some cases) Replace (3Rs) in vitro and in vivo (animal and human) experiments.

The next step will be to have the document elaborated and approved by ICH, International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (www.ich.org); ICH is the generator of Good Clinical Practice and gathers FDA, EMA and other relevant regulatory agencies and associations. 

Good Simulation Practices is going to play an essential role soon. In the coming years, scientific research on in silico medicine must become less and less speculative, and increasingly translational, that is to say, immediately applicable and useful for clinical and industrial applications. This is only possible if researchers in laboratories and universities also start developing their models following good simulation practice.

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