In the March/April 2017 issue of Pharmaceutical Statistics, EFSPI/PSI's Special Interest Group (SIG) for Modelling and Simulation published a Proposed Best Practice for Projects Involving Modelling and Simulation. The Board of PSI had recommended that the proposal be submitted for publication and has now formally endorsed the Best Practice - you can see the Best Practice document at http://onlinelibrary.wiley.com/doi/10.1002/pst.1789/epdf
. (Please note that in order to gain free access as a PSI member you will need to enter the Wiley website via the PSI website).
The Best Practice defines modelling and simulation, gives guidelines for when to use simulation, and provides a checklist of key items that should be included in a specification for a modelling/simulation task. The Best Practice recognizes that modelling and simulation is used for a huge variety of objectives and may have greater or lesser importance and impact. Because of this, it allows flexibility in the level of pre-specification and documentation required for Best Practice, but at the same time requires that the level of pre-specification itself be documented and justified. The publication includes two example or template specifications as online supplements, one a specification for a low-impact use of modelling and simulation, the other, more detailed, for a task with higher impact.