English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Tools annual

Global: Zendy Free Plan

Global: Zendy Tools monthly

Global: Zendy Plus monthly

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

Examination of Selection of Immediate Release Dissolution Acceptance Criteria