ANVISA - SABE [Design Issues]

posted by Samaya B – India, 2015-04-27 14:03 (3581 d 15:02 ago) – Posting: # 14743
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Hi Luvblooms

❝ You just got lucky!!!! That's all I will say as per my interaction with ANVISA. They are tough nut to crack!!


True.. that is the reason I have mentioned to submit a protocol with replicated design for ANVISA review before initiating a study.

❝ Does this mean that widening given only for Cmax and max limit will be 69-143?


During ANVISA review, the agency had asked us to follow EU guidance for widening. (so I assume widening would be applicable to Cmax only).

❝ Any specific reason behind it?


Not sure!


Regards,
Samaya

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