Outliers US FDA submission [Outliers]

posted by Chiku – India, 2013-03-04 12:56 (4212 d 08:21 ago) – Posting: # 10149
Views: 6,540

Dear Elmaestro,

Thanks for the promt reply.

Yes we have done Box plot analysis, Lund's test for statistical out lier.

Reference conc was detected so may be not absorbed (reference is OROS tablet). T/R for that particular subject was 1300.

There was no unusual observation @ clinic or bioanalytical.

Regards,

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