Fully Replicate Study [Study As­sess­ment]

posted by NK – India, 2021-04-26 09:46 (223 d 16:33 ago) – Posting: # 22323
Views: 1,406

Dear All,

We did BE study (both fasting and fed) for ER formulation of a drug (HVD), with fully replicated design (RTRT/TRTR) for USFDA. The protocol says, plasma samples from subjects who complete all the four periods will be analyzed and will be included for PK and statistical analysis.

Where we observed following:Can we include Subject A & B for statistical analysis (protocol not specified about handling subject with three periods data. (ie. one T & two R and one R & Two T).

To handle this kind of situation in future, Can we mention in the protocol to exclude the subject (outlier) with above scenario.

Thanks in advance

Regards
NK


Edit: Category changed; see also this post #1[Helmut]

Complete thread:

Activity
 Admin contact
21,786 posts in 4,557 threads, 1,548 registered users;
online 13 (1 registered, 12 guests [including 7 identified bots]).
Forum time: Monday 01:19 CET (Europe/Vienna)

The history of statistics is like a telephone directory:
the plot is boring, full of numbers and the cast is endless.    Stephen Senn

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