What a mess! [Regulatives / Guidelines]

posted by Shuanghe  – Spain, 2015-09-25 18:32 (3423 d 15:07 ago) – Posting: # 15470
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Dear Helmut,

❝ ... Given the reported CVs (@Shuanghe: Did you ever observe one <21.42%?) downscaling would be unlikely.


For AUC, yes. as low as 15% under fed, but for Cmax, my lowest ISCV of R is about 24% under fed.

❝ I expect that the FDA’s guidance for yet another NOAC (apixaban) will be revised as well.


I'd expect it the same as those two.

All the best,
Shuanghe

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