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Back to the forum  Query: 2018-04-25 02:47 CEST (UTC+2h)
 

oral powder with water acceptable? [Regulatives / Guidelines]

posted by ElMaestro - Denmark, 2018-04-16 14:14  - Posting: # 18688
Views: 544

Hello Christian,

'narrowly failed' suggests that your product may indeed be BE but that you lacked sample size. This scenario if often a candidate for a repeat trial, but it comes down to the specifics and sometimes even national habits.
Can you show the numbers for the CIs?

Having said that, an oral powder is often given with something that isn't chewed. Can you shed a little more light on your previous trial: results, administration, food/water restriction post dose, and so forth?

If your product is approved only along with water, which is indeed a quite possible future outcome if you go down that route, then you may run into some substitution issues such as getting an approval but not the substitution in some countries. Do you aim for a 10.1/2 or a 505(j), or what country(ies)?

I could be wrong, but…


Best regards,
ElMaestro

- Bootstrapping for dissolution data is a relatively new hobby of mine.

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