Transl Clin Pharmacol.  2014 Dec;22(2):78-82. 10.12793/tcp.2014.22.2.78.

On comparison of SAS codes with GLM and MIXED for the crossover studies with QT interval data

Affiliations
  • 1Divison of Mathematics, College of Science and Technology, Hongik University at Sejong, Sejong 339-701, Korea. kmchoi@hongik.ac.kr
  • 2Department of Clinical Pharmacology and Therapeutics, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 137-701, Korea.
  • 3PIPET (Pharmacometrics Institute for Practical Education & Training), Seoul 137-701, Korea.

Abstract

The structural complexity of crossover studies for bioequivalence test confuses analysts and leaves them a hard choice among various programs. Our study reviews PROC GLM and PROC MIXED in SAS and compares widely used SAS codes for crossover studies. PROC MIXED based on REML is more recommended since it provides best linear unbiased estimator of the random between-subject effects and its variance. Our study also considers the covariance structure within subject over period which most PK/PD studies and crossover studies ignore. The QT interval data after the administration of moxifloxacin for a fixed time point are analyzed for the comparison of representative SAS codes for crossover studies.

Keyword

QT interval; PROC GLM; PROC MIXED; Crossover studies; repeated measures

MeSH Terms

Cross-Over Studies*
Therapeutic Equivalency

Reference

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