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Back to the forum  Query: 2017-11-23 19:25 CET (UTC+1h)
 

Enlighten me please [Regulatives / Guidelines]

posted by jag009 - NJ, 2017-09-07 06:16  - Posting: # 17790
Views: 644

Hi ElMaestro,

» Hi Jag,I am sure that unless you find a really good reason buried in the material on the originator available via FOI the reason is going to be very hard to identify. :-|

Even in the NDA the levels of all three analyte plus another metabolite (which FDA doesn't want to see) were reported...

Oh well...
J

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