The objectives of this study were to assess the effect of food and gender on the pharmacokinetics of avitripan. A group of 12 healthy men and 12 healthy women was administered a single 50 mg dose of avitriptan capsule under fasting conditions and 5 min after a high-fat breakfast. The two treatments
DESIGN AND ANALYSIS OF INTRA-SUBJECT VARIABILITY IN CROSS-OVER EXPERIMENTS
β Scribed by VERNON M. CHINCHILLI; JAMES D. ESINHART
- Publisher
- John Wiley and Sons
- Year
- 1996
- Tongue
- English
- Weight
- 953 KB
- Volume
- 15
- Category
- Article
- ISSN
- 0277-6715
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β¦ Synopsis
Recently, interest has grown in the development of inferential techniques to compare treatment variabilities in the setting of a cross-over experiment. In particular, comparison of treatments with respect to intrasubject variability has greater interest than has inter-subject variability. We begin with a presentation of a general approach for statistical inference within a cross-over design. We discuss three different statistical models where model choice depends on the design and assumptions about carry-over effects. Each model incorporates t-variate random subject effects, where t is the number of treatments. We develop maximum likelihood (ML) and restricted maximum likelihood (REML) approaches to derive parameter estimators and we consider a special case in which closed-form expressions for the variance component estimators are available. Finally, we illustrate the methodologies with the analysis of data from three examples.
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