chirayu
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2011-08-04 17:49
(5033 d 03:23 ago)

Posting: # 7260
Views: 4,231
 

 Average scale BE study [RSABE / ABEL]

Dear All,

Plz give your valuable suggestion on below mentioned situation.

For reference replicated design, in case of missing observation, if the reference treatment data is available in two periods for more number of subjects, but both test and reference treatment data is available for lesser number of subjects (i.e. subjects data is available for all three periods) then on what no. of subjects the Statistical evaluation should be done ? i.e. if we calculate reference variability (or standard deviation) on available R-R data, then should this variability be considered in Scaling & calculation of 95% upper bound or it should be done on lesser number of subjects completing both test and reference treatment and having all three period data?


Edit: Category changed. [Helmut]
Helmut
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Vienna, Austria,
2011-08-05 12:06
(5032 d 09:06 ago)

@ chirayu
Posting: # 7262
Views: 3,481
 

 Average scale BE study

Dear Chirayu!

One suggestion. See EMA’s recent Q&A document (Section 11). The two datasets (partial replicate and full replicate) contain missing periods. Compare your code’s results (from whatever software) to reported results (EMA: Methods A/B, FDA: Method C).
If you don’t want to extract the data from the PDF, you may download them here in M$-Excel format.

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