Bioequivalence and Bioavailability Forum

Pankaj Bhangale
☆

India,
2011-09-03 12:37
(5059 d 14:24 ago)

Posting: # 7332
Views: 6,301

Four Period Fully Replicated Crossover With Multiple Groups [General Statistics]

Dear All,

Four period replicated crossover BE Study with 72 subjects. The subjects are divided in two groups with 36 Subject due to insufficient clinical capacity.

According to US-FDA Guidance for Industry, SAS code with ANOVA model to be used for the analysis of replicate crossover designs without groups is as follows.

proc mixed data=replicate;

class sequence period formulation subject;

model LCmax=sequence period formulation/ddfm=satterth;

random formulation/type=FA0(2) sub=subject G;

repeated/GRP=formulation sub=subject;

lsmeans formulation;

estimate 'Test vs Reference' formulation -1 1/CL alpha=0.10;

run;

Modified above SAS code with multiple groups is as follows:

proc mixed data=replicate;

class sequence period group formulation subject;

model LCmax=sequence period formulation group/ddfm=satterth;

random formulation/type=FA0(2) sub=subject G;

repeated/GRP=formulation sub=subject;

lsmeans formulation;

estimate 'Test vs Reference' formulation -1 1/CL alpha=0.10;

run;

Is it correct SAS code with ANOVA model for the analysis of replicate designs with multiple groups?

Regards,
Pankaj Bhangale

suchit_bhavsar
★

India,
2014-05-28 10:38
(4061 d 16:24 ago)

@ Pankaj Bhangale
Posting: # 13011
Views: 4,149

Four Period Fully Replicated Crossover With Multiple Groups

Post reply

Dear All,
I have tried the same code with group as follows:

❝ proc mixed data=replicate;

❝ class sequence period group formulation subject;

❝ model LCmax=sequence period formulation group group*formulation/ddfm=satterth;

❝ random formulation/type=FA0(2) sub=subject G;

❝ repeated/GRP=formulation sub=subject;

❝ lsmeans formulation;

❝ estimate 'Test vs Reference' formulation -1 1/CL alpha=0.10;

❝ run;

the code was successfully executed without any error, kindly suggest Is this right procedure.

Thanks & Regards,
Suchit Bhavsar

Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]

Four Period Fully Replicated Crossover With Multiple Groups [General Sta­tis­tics]

Four Period Fully Replicated Crossover With Multiple Groups

Four Period Fully Replicated Crossover With Multiple Groups [General Statistics]