EMA: Method A or B [RSABE / ABEL]

posted by Mohamed Yehia  – Egypt, 2018-01-23 12:56 (2336 d 15:56 ago) – Posting: # 18264
Views: 4,063

❝ […] In partial replicate designs (TRR|RTR|RRT) I suggest to specify two analysis sets if data of the third period in sequence RRT is missing:

  1. Exclude subjects from the assessment of BE since the GL requires at least one treatment of T and R.

  2. Keep subjects for the estimation of CVwR.

Yes :-)

❝ ❝ I want a clarified answer please with guideline reference if applicable.

❝ The Q&A document

Thanks for the link

❝ From a purely statistical perspective my preferences are: Method C ≫ Method B > Method A. I don’t like the idea to treat subjects as a fixed effect.

That's what I believe too ;-)
Check this link: doi:10.12793/tcp.2014.22.2.78

❝ Given the observations from above, a sponsor probably would fair best with Method A only.

Of course :-D

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! doi corrected. [Helmut]

Complete thread:

UA Flag
 Admin contact
23,057 posts in 4,840 threads, 1,641 registered users;
138 visitors (0 registered, 138 guests [including 80 identified bots]).
Forum time: 05:53 CEST (Europe/Vienna)

If you tell the truth you don’t have to remember anything.    Mark Twain

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