Outliers US FDA submission [Outliers]

posted by Chiku – India, 2013-03-04 12:30 (3861 d 15:16 ago) – Posting: # 10147
Views: 7,079

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)


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