Application of the Montecarlo Simulation for risk assessment in the Development of an analytical method according to the principles of quality by design (QbD)

Montecarlo simulation is a powerful tool to identify influencing factors and intervals in which carry out analytical development tests, although as it mathematical model, must be experimentally confirmed. The results obtained presented the work confirm that this allows previous analysis of sources variability its importance within risk assessment phase. With this, subsequent experimental confirmation mainly focused on use variables revealed with simulation, saving resources time do not add value global process development. Keywords: simulation; QbD; method