PROC GLM OR PROC MIX FOR BIOEQUIVALENCE STUDY

superbibi — Fri, 28 Jun 2019 15:34:16 GMT

Hi SAS Users,

I need to test bioequivalent between two treatment. Bioequivalence is defined as 90% CI of the geometric mean ratio between treatment and reference lines within 0.8 and 1.25.

I have a sample data set that is from a guideline and I want to write the code which can generate the same outputs as the guideline.

I used the ID, seq, period, AUCt data in Table A1-E and A1-F from the linked PDF. It should come up with the output on Table A1-H and A1-I.

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/bioavailability-bioequivalence/conduct-analysis-comparative.pdf

I also attached the sas data set here.

I have tried several sets of code and cannot find the same outcome. Particularly the output on Table A1-I (parameter as subject(seq) and residual with their variance. How should I modify the code?

/* using proc mixed*/

PROC MIXED DATA = MBHC.SAMPLE;
CLASS ID SEQ PERIOD FORMULATION;
MODEL LNAUC =SEQ PERIOD FORMULATION/ DDFM = SATTERTH ;
RANDOM FORMULATION/TYPE = FA0(2) SUB = ID;
REPEATED/GRP = FORMULATION SUB = ID;
ESTIMATE "T VS. R" FORMULATION 1 -1/CL ALPHA = 0.1;
RUN;


/* using GLM*/

PROC GLM DATA=MBHC.SAMPLE ;

   CLASS ID SEQ PERIOD FORMULATION  ;
   MODEL LNAUC =SEQ PERIOD FORMULATION;

RUN ;

Output I want:

Thank you.

topic PROC GLM OR PROC MIX FOR BIOEQUIVALENCE STUDY in Statistical Procedures

PROC GLM OR PROC MIX FOR BIOEQUIVALENCE STUDY