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. 2024 Jun 11;15(2):732–752. doi: 10.1007/s13346-024-01633-7

Table 13.

Updated REM presenting risk assessment levels of ASD formulation and the respective process parameters

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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