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How to simulate a replicate design bioequivalence study

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How to simulate a replicate design bioequivalence study

I have data from a two-way cross over Bioequivalence study for a test product and a reference product and I fit the data to obtain the individual subject parameters.  I then can use SAS PROC CORR to obtain the variance/covariance matrix which would allow me to do a simulation by changing the test parameter for rate constant of absorption and proceed to simulate a two-way crossover Bioequivalence study.  I can then take the Cholesky of the var/cov matrix  using SAS IML to get the lower triangular matrix to conduct simulations usinf SAS IML.

I wanted to know is there any way to  introduce random error into the parameters of the two-way crossover study to have those parameters be similar to what one might see if the two-way crossover study were replicated?

Two-way  Design

Seq1         AB

Seq1         BA

Replicate Design

Seq1  A B  A B

Seq2  B A  B  A

SAS Super FREQ
Posts: 3,615

Re: How to simulate a replicate design bioequivalence study

Yes. However, I am not a biostatistician and I do not understand your jargon. Can you explain in simple English what you are trying to do and include some data?  Are the data multivariate normal? Or are they multinomial (correlated categorical)?  If so, the RANDNORMAL function and the RANDMULTINOMIAL functions might help you.

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