Partial Replicate with Groups [RSABE / ABEL]

posted by MGR  – India, 2015-02-03 10:46 (4164 d 11:28 ago) – Posting: # 14357
Views: 5,289

Hi All,

We have done a three way partial replicate (TRR|RTR|RRT) with 60 subjects in 3 groups each of 20 subjects with 45 days gap due to the subjects turnover rate for USFDA Submission.

So my question is:
  1. Can we use group effect into the stat analysis?
  2. if so how we can include those to ilat and dlat?
  3. how can we add group effect into the analysis i.e, glm procedure for calculating the limits?
I have searched the USFDA site but i didn't find any article on this.

If there is any USFDA guideline/article, please share.

Thanks in advance.

Edit: Category changed. [Helmut]
—
Regards,
MGR

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