jag009
★★★

NJ,
2013-04-08 22:18
(4419 d 08:31 ago)

Posting: # 10373
Views: 5,176
 

 4way full replicate SAS routine from FDA guidance [RSABE / ABEL]

Hi,

Does anyone have trouble trying out the 4way full replicate SAS code from FDA's progesterone guidance? I tried it with the EMEA 4-way datasets but I am stuck at the merging routine for "test1 test2 ref1 ref2" and the ilat and dlat calculation.

Determine Iij andDij
data scavbe;
merge test1 test2 ref1 ref2;
by seq subj;
ilat=0.5*(lat1t+lat2t-lat1r-lat2r);
dlat=lat1r-lat2r;
run;


For some reason SAS won't compute ilat and dlat.

Thanks
John


Edit: Category changed. [Helmut]
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2013-04-09 04:58
(4419 d 01:51 ago)

@ jag009
Posting: # 10377
Views: 4,326
 

 Merging problems?

Hi John,

❝ I tried it with the EMEA 4-way datasets but I am stuck at the merging routine for "test1 test2 ref1 ref2" and the ilat and dlat calculation.


EMA’s data set I is nasty: imbalanced and incomplete. Maybe you have to adjust your merge-command? If you want to compare it to results obtained in Phoenix, see here.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
jag009
★★★

NJ,
2013-04-09 22:12
(4418 d 08:37 ago)

@ Helmut
Posting: # 10385
Views: 4,194
 

 Merging problems?

Hi Helmut,

❝ If you want to compare it to results obtained in Phoenix, see here.


I figured it out...

Here is mine results
Theta         y          s2WR      sWR     T/R Ratio  critBound
0.79669   -0.15879     0.19931   0.44645    115.461   -0.092076


Yours from Winnonlin
pointest    Title      sWR        boundy       critbound   CVwr  Assessment
1.1546132  average  0.44644551  -0.12298597  -0.092076336  46.96  RSABE


I need to check boundy...

Thanks
John
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2013-04-10 19:32
(4417 d 11:18 ago)

@ jag009
Posting: # 10400
Views: 4,361
 

 critbound?

Hi John,

❝ I figured it out...


And how? Maybe others are interested as well. ;-)

Here is mine results

❝ Theta         y          s2WR      sWR     T/R Ratio  critBound

❝ 0.79669   -0.15879     0.19931   0.44645    115.461   -0.092076


Yours from Winnonlin

❝ pointest    Title      sWR        boundy       critbound   CVwr  Assessment

❝ 1.1546132  average  0.44644551  -0.12298597  -0.092076336  46.96  RSABE


❝ I need to check boundy...


Do you get a different value? Can’t imagine since both your y and critbound are the same as mine. χ²0.95,71=91.67 and boundy=y·df/χ² or -0.15879×71/91.67=-0.12299.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
jag009
★★★

NJ,
2013-04-10 23:22
(4417 d 07:27 ago)

@ Helmut
Posting: # 10401
Views: 4,196
 

 critbound?

Hi Helmut,

1) I made a boo boo on my proc sort and merge command in SAS. That was why the merge didn't work properly. I have to be careful on proc sort and subsequence merge command.

2) My boundy is the same as your boundy (-0.12298597).
I had a typo'd on my output. -0.15879 was for y.

It's all good. The EMA data is fine.

Thanks
John
UA Flag
Activity
 Admin contact
23,424 posts in 4,927 threads, 1,671 registered users;
121 visitors (0 registered, 121 guests [including 35 identified bots]).
Forum time: 06:50 CEST (Europe/Vienna)

Don’t undertake a project
unless it’s manifestly important
and nearly impossible.    Edwin H. Land

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5