dinesh prabhu
●    

2012-04-28 08:24
(4765 d 18:34 ago)

Posting: # 8470
Views: 4,018
 

 Reference replicate design [RSABE / ABEL]

Dear All

We completed a reference replicate design (3 WC) for FDA submission


while calculating the Geo mean ratio in SABE we had a confusion in using the SAS codes as below

we calculated the GMR as per the below code

pointest=exp(estimate);

poinREF=exp(estimate);

data dglmno;
set dglmn;
DIFF= (pointest-poinREF)**2;
theta=((log(1.25))/0.25)**2;
y=-theta*s2wr;
boundy=y*dfd/cinv(0.95,dfd);
ucl= DIFF- boundy;
lcl= DIFF+ boundy;
sWR=sqrt(s2wr);
critbound=(x+y)+sqrt(((boundx-x)**2)+((boundy-y)**2));
Geomean_ratio= pointest/ poinREF;


But other statistician used diffrent code as below

pointest=exp(estimate);

data dglmno;
set dglmn;
theta=((log(1.25))/0.25)**2;
y=-theta*s2wr;
boundy=y*dfd/cinv(0.95,dfd);
sWR=sqrt(s2wr);
critbound=(x+y)+sqrt(((boundx-x)**2)+((boundy-y)**2));
Geomean_ratio= pointest;


So kinldy help me out in differntiating in which one is the correct way to calculate the GMR

Thanks

Dinesh


Edit: Category changed. [Helmut]
Helmut
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Vienna, Austria,
2012-04-28 13:38
(4765 d 13:20 ago)

@ dinesh prabhu
Posting: # 8473
Views: 3,261
 

 Use FDA’s SAS code!

Dear Dinesh!

❝ We completed a reference replicate design (3 WC) for FDA submission


So why didn’t you employ FDA’s code exactly as given in the guidance? See this recent thread.

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