Examination of Selection of Immediate Release Dissolution Acceptance Criteria

摘要: Introduction Prior to discussing this issue,it is impo rt a nt that one be familiar with the immediate re l e s c ce p t n cri te ria of USP Dissolution t, h own ow in Table 1. For US submission, order define dissolution spe i f cat o , sponsor must pro pose ‘Q’ value and time po (e. g. ,30 minutes or 45 m u tes) at which data will eva ate d against appro ri .In many instance s, disagre tween FDA on values for co ct ‘Q’, leading approva ays roversy g ato ry agency. This paper illustrate ve rvat Stage 1 acce those other stages.This pape r rates major issue ressed when approaching topic rge diffe discri ability initial subsequent stages .Another bro ht fo rth raditional establishment Q only 5 unit incre s.This via theory examples b nted by above two issues.Fi y, rticle pre an alte rn dat roach could used arri ntial s.