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

Abstract

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