Table 13.
Updated REM presenting risk assessment levels of ASD formulation and the respective process parameters
IDR Intrinsic dissolution rate, HSH High-shear homogenization, HPH High-pressure homogenization, Low low-risk parameter, Medium medium risk parameter, High high-risk parameter
Despite addressing formulation aspects, the AS:S ratio was herein considered as a CPP, given the controlled ensured by the technique upon the mixture of both phases
