Partial replicate for USA [RSABE / ABEL]

posted by balakotu – India, 2013-01-10 09:37 (4498 d 12:58 ago) – Posting: # 9810
Views: 5,534

Dear All,

Recently I have done one partial replicate study for USFDA(N=15).

In our study the Swr < 0.294 for AUCt and AUCi then I use the unscaled average bioequivalence approach as given below

Calculation of unscaled 90% bioequivalence confidence intervals:
PROC MIXED
data=pk;
CLASSES SEQ SUBJ PER TRT;
MODEL LAUCT = SEQ PER TRT/ DDFM=SATTERTH;
RANDOM TRT/TYPE=FA0(2) SUB=SUBJ G;
REPEATED/GRP=TRT SUB=SUJ;
B ESTIMATE 'T vs. R' TRT 1 -1/CL ALPHA=0.1;
ODS OUTPUT LSMEANS=LSM
ods output Estimates=unsc1;
run;

Based on the above program I got below WARNING for ESTIMATES and LSMEANS.
WARNING: Stopped because of infinite likelihood.
NOTE: The data set WORK.COVEST1 has 5 observations and 4 variables.
WARNING: Output 'ESTIMATES' was not created.  Make sure that the output object name, label, or path is spelled correctly. Also, verify that the appropriate procedure options are  used to produce the requested output object. For example, verify that the NOPRINT option is not used.
WARNING: Output 'LSMEANS' was not created. Make sure that the output object name, label, or path is spelled correctly. Also, verify that the appropriate procedure options are used to produce the requested output object.  For example, verify that the NOPRINT option is not used.
WARNING: Output 'G' was not created. Make sure that the output object name, label, or path is spelled correctly. Also, verify that the appropriate procedure options are used to produce the requested output object. For example, verify that the NOPRINT option is not used.


Please clarify the above program. If I am removing “RANDOM TRT/TYPE=FA0(2) SUB=SUBJ G”; in the above program I am getting the results.
Please clarify whether I have to remove above statement in the program.

Regards
Kotu.

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