Susanh
☆    

Iceland,
2020-12-04 16:14
(44 d 16:26 ago)

Posting: # 22114
Views: 420
 

 partial AUCs for locally acting MR [Design Issues]

Dear all,

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.

Does anyone have suggestions how to approach this problem?

The modified release guideline (Guideline on the pharmacokinetic and clinical evaluation of modified release dosage forms EMA/CHMP/EWP/280/96 Rev1) suggests that the cut-off should be half the dosing interval but I fear that this may not be acceptable.

Thanks in advance,

Susan
jag009
★★★

NJ,
2020-12-05 08:01
(44 d 00:39 ago)

@ Susanh
Posting: # 22116
Views: 342
 

 partial AUCs for locally acting MR

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
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