Translational and Clinical Pharmacology · 2014 · 10 citations · 15 references
PharmacyBiostatisticsPharmacologyBioequivalenceNoncompartmental AnalysisPopulation PharmacokineticsBioequivalence AssessmentBioequivalence Study DesignCrossover DesignsStatistical Analysis Of BioequivalenceBest Linear Unbiased EstimationCovariance StructureCovariance Structure AnalysisCovariance Structure ModelingQt Interval AnalysisQt Interval AssessmentSubject EffectsVariance-covariance Structure
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 administra tion of moxifloxacin for a fixed time point are analyzed for the comparison of representative SAS codes for crossover studies.
15
Mixed-Effects Models in S and S-PLUS
Technometrics · 2001 · 9.4K citations · Full text
Fundamentals of Biostatistics.
Annals of Internal Medicine · 1969 · 4.6K citations
Fundamentals of Biostatistics.
Richard G. Cornell, Bernard Rosner · Journal of the American Statistical Association · 1987 · 1.6K citations