US FDA-Cmin in Bioequivalence criteria [Regulatives / Guidelines]

posted by KR – India, 2010-03-19 15:26 (5946 d 19:51 ago) – Posting: # 4940
Views: 2,227

Dear Mr. Hitesh,

As per my knowledge, Cmin is not required for the establishment of bioequivalence in USFDA submission. Bioequivalence limits will be applied to only AUCtau and Cmax.

I hope this helps...

With regards,

KR

Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

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