One fail and one success, should it be accepted? [Regulatives / Guidelines]

posted by ElMaestro  – Belgium?, 2019-07-17 12:33 (386 d 05:49 ago) – Posting: # 20382
Views: 1,429

Hello ssussu,

» We did a BE trial using a partial replicated design(TRR,RTR,RRT), but it was fail to demonstrate BE because the Cmax of one subject after administration of test drug was too much higher than reference drug, and when excluding the data of this subject, the results showed bioequivalent. But actually there were no reason to exclude the data from this subject.
» And we conducted another BE trial, this time using full replicated design(TRTR,RTRT), and this time the result showed bioequivalent.
» What I want to ask is, whether the second trial which showed bioeuquivalent would be accepted by agency. Any suggestions about this if we want to convince the agency to accept the successful one?

Not all agencies would accept it without a very good justification. I am sure you have one since the trial was repeated.

Use the forum's private channel and I will ask a few q's for my own clarification and give you a push in the right direction if the agency is CFDA, USFDA, EMA, TGA, ANVISA, HC or PMDA :-D

I could be wrong, but...

Best regards,

"Pass or fail" (D. Potvin et al., 2008)

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