Enlighten me please [Regulatives / Guidelines]

posted by jag009  – NJ, 2017-09-07 08:16 (3213 d 09:30 ago) – Posting: # 17790
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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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