ssussu
☆    

China,
2019-07-17 11:45
(792 d 09:13 ago)

Posting: # 20381
Views: 2,227
 

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

Dear guys,
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?


Thanks
ElMaestro
★★★

Denmark,
2019-07-17 14:33
(792 d 06:26 ago)

@ ssussu
Posting: # 20382
Views: 1,883
 

 One fail and one success, should it be accepted?

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

Pass or fail!
ElMaestro
jag009
★★★

NJ,
2019-07-18 19:14
(791 d 01:45 ago)

@ ssussu
Posting: # 20394
Views: 1,795
 

 One fail and one success, should it be accepted?

» Dear guys,
» 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 about AUC from that subject?

J
WhiteCoatWriter
☆    

India,
2019-07-23 14:18
(786 d 06:41 ago)

@ ssussu
Posting: # 20438
Views: 1,740
 

 One fail and one success, should it be accepted?

Hi
ssussu,

Most of us come across such situations where we have a study that has not been bio equivalent because of one subject and after all the investigations there has been no reason to exclude the subject and thereby accept the fate of the study and repeat the study with the same formulation. However, in your case, if the formulation batch remains the same, I guess you can proceed with the ANDA application while you must however be ready with a strong justification for why you chose a fully replicated design and describe in detail about it (from what I assume is a case of a highly variable drug).

Thanks and Regards
Dr Anonymous
(WhiteCoatWriter)
Activity
 Admin contact
21,678 posts in 4,533 threads, 1,541 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time: Thursday 20:59 CEST (Europe/Vienna)

Ignorance more frequently begets confidence
than does knowledge.    Charles Darwin

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5