Bioequivalence and Bioavailability Forum 12:13 CET

Main page Policy/Terms of Use Abbreviations Latest Posts

 Log in |  Register |  Search

Rules acc. to Health Canada [Outliers]

posted by zizou - Plzeň, Czech Republic, 2019-02-06 20:52  - Posting: # 19886
Views: 304

Hello everybody and nobody.

I'm just thinking about another slightly related issue.

Assume that there is an outlier in the study for Health Canada.
If the outlier wasn't removed, we would get GMR1, intra-subject CV1 and corresponding 90% CI.
However the outlier is removed according to the study protocol and the results are different:So when outlier is removed as planned, my question is: "Will be the patient's risk (Type I Error) still lower or equal to 5%?"

Assume the border case with true GMR 0.8 and intra-subject CV e.g. 30%. The TIE (in the border case equal to power) in standard 2x2 BE is 5%. However I am not sure if it is the same with exclusion of outlier. So do we get some bonus power as intra-subject CV will be always lower after exclusion? I just imagine the simulation - individual simulated cases with:So I would expect the TIE slightly over 5%. (Wenn ich mich nicht irre.)

Maybe someone could try to simulate it - TIE with the exclusion of outlier(s) for BE in 2x2.
I am not familiar with outliers and complicated simulations - simulate data (true GMR 0.8 and intra-subject CV 30%), look for outliers and exclude them (it could end with lowering the intra-subject CV), calculate 90% CI, and do it million times. The result will be probably close to 5%, but still higher?

Best regards,
zizou

Complete thread:

Activity
 Mix view
Bioequivalence and Bioavailability Forum |  Admin contact
19,187 posts in 4,084 threads, 1,308 registered users;
online 7 (0 registered, 7 guests [including 4 identified bots]).

In these days, a man who says a thing cannot be done
is quite apt to be interrupted by some idiot doing it.    Elbert Green Hubbard

The BIOEQUIVALENCE / BIOAVAILABILITY FORUM is hosted by
BEBAC Ing. Helmut Schütz
HTML5 RSS Feed