jag009
★★★

NJ,
2013-10-01 17:14
(4650 d 11:11 ago)

Posting: # 11582
Views: 3,650
 

 FDA Submission: Failed and pilot studies [Regulatives / Guidelines]

Post reply
Hi guys,

Does anyone know what FDA requires to submit for failed and/or pilot study(s)? Would a study synopsis (with results) and DBE table be sufficient?

Thanks

John
 
Ohlbe
★★★

France,
2013-10-01 17:41
(4650 d 10:44 ago)

@ jag009
Posting: # 11584
Views: 3,079
 

 FDA Submission: Failed and pilot studies

Post reply
Hi John,

The Guidance on submission of summary BE data for ANDAs refers in lines 90-96 to the summary tables which can be found on FDA's web site.
—
Regards
Ohlbe
 
jag009
★★★

NJ,
2013-10-01 18:33
(4650 d 09:52 ago)

@ Ohlbe
Posting: # 11585
Views: 3,049
 

 FDA Submission: Failed and pilot studies

Post reply
Thanks Ohlbe

John
 
UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,571 registered users;
131 visitors (0 registered, 131 guests [including 16 identified bots]).
Forum time: 04:26 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