Promazine hydrochloride Pharmacokinetics [Design Issues]

posted by The Outlaw Torn – Europe, 2015-05-14 13:52 (2611 d 05:27 ago) – Posting: # 14817
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» WEU might be an option, but how to prove significant use within the EU for the last 10 years?

I'm not sure you'd have to prove significant use, just use (and point out One Flew Over the Cuckoo's Nest for it's historical use :-P). We certainly didn't have to prove this, though this was not a problem with our API. We did encounter some push back based on the ERA as this product was not in all markets (and not in the RMS market!!!) and not everyone accepted the standard statement that a full ERA is not necessary, etc. And, get this, a bioequivalence study was requested for this well established use procedure! :surprised: We sort of provided one, but with caveats I don't care to get into at this point as they won't help pjs.

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