Outliers US FDA submission [Outliers]

posted by Chiku – India, 2013-03-04 12:30 (4042 d 23:40 ago) – Posting: # 10147
Views: 7,300

Dear all,

We received Following results for an ER product for US market:

All Subjects
Cmax: 115.45 (106.16 - 125.16)
AUC0-t: 118.53 ( 108.52 - 129.46)
AUC0-inf: 117.81 (108.17 - 128.32)

After reviewing, the results we observed that one particular subject is qualifying as an statistical outlier for all the three PK parameters i.e Cmax, AUC0-t and AUC0-inf (Reference product was not released at all). The data is within BE acceptance limits after deleting the subject , here is the data for your reference.

After removing statistical outlier:

Cmax: 112.70 (104.47 - 121.59)
AUC0-t: 115.37 ( 106.67 - 124.78)
AUC0-inf: 114.88 (106.40 - 124.02)

Still the data is on Boarder case, kindly suggest a way forward:

1. Submit as such data (wait for deficiency, upon deficiency redosing study) will it be acceptable or “refuse to file”?
2. Redosing study and then file the ANDA (this will take 5 months as we do not have BE NOC as of now)

Regards,

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
116 visitors (0 registered, 116 guests [including 8 identified bots]).
Forum time: 12:10 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

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