oral powder with water acceptable? [Regulatives / Guidelines]

posted by chris089 – Munich, Germany, 2018-04-19 18:18 (2052 d 22:34 ago) – Posting: # 18700
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It does suck, doesn't it? Even more so as I see another company who has almost the same formulation and got lucky. But then, good and bad luck is part of statistics (they had fewer samples - broader CI, but slightly higher). Or they used water and it's not mentioned in the public AR...

Excuse me, but being a newbie, I need some translations:

❝ Perhaps I would approach the friendly people in Sweden, mention SE as RMS and AT+DE as CMS and see if they (SE) are lenient on you.

approach = "scientific advise"?
lenient = "accept our results as BE"? or "give us the marketing authorisation if we pass BE with water in an additional study"?

❝ One last thing: If the abs is "very fast", and I cannot quantitatively define it very well as it also has to do with your sampling regimen, then perhaps you want to try to look into partial AUCs up to around the time of Cmax.

What might be the outcome of that?
There seem to be sufficient samples around tmax (10, 20, 30min, every 15min til 2h, every 30min til 4h, ...)

❝ I hope others will chime in with opinions here. This is a great case, actually.

Glad to hear that. Initially, I was hesitant to ask.

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