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Registerpartial AUCs for locally acting MR [Design Issues]
Hi,
» I’m involved in the development of a MR generic drug that is locally acting in the GI tract. Despite the very helpful new EMA guideline (Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract, CPMP/EWP/239/95 Rev. 1, Corr.1*) I´m struggling with designing the BE studies to support submission in EU.
»
» Most problematic is the justification of the cut-off for the required partial AUCs.
Something like this in US for mesalamine ER?
https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022301.pdf
J
» I’m involved in the development of a MR generic drug that is locally acting in the GI tract. Despite the very helpful new EMA guideline (Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract, CPMP/EWP/239/95 Rev. 1, Corr.1*) I´m struggling with designing the BE studies to support submission in EU.
»
» Most problematic is the justification of the cut-off for the required partial AUCs.
Something like this in US for mesalamine ER?
https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_022301.pdf
J
Complete thread:
- partial AUCs for locally acting MR Susanh 2020-12-04 16:14 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- partial AUCs for locally acting MRjag009 2020-12-05 08:01
- partial AUCs for locally acting MR Kumarnaidu2 2021-05-28 11:55
- partial AUCs for locally acting MR dshah 2021-05-31 08:47
- partial AUCs for locally acting MR Kumarnaidu2 2021-05-28 11:55
- partial AUCs for locally acting MRjag009 2020-12-05 08:01
Ing. Helmut Schütz