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PI-77Circadian rhythm modeling of continuous heart rate data in a pharmacokinetics study oforos methylphenidate in healthy adults by PARASRAMPURIA, D; GELOTTE, C is a Medicine article available to read on EtoBox.

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BACKGROUND: Cost-efficient trial designs have drawn considerable attention (Pharmaceutical Statistics; 2005; 4:152-160). Dropouts often occur in clinical trials. This study is to investigate the effect of dropouts on the cost efficiency of five commonly used, statistically optimal or near-optimal higher-order crossover designs for comparative bioavailability studies. METHODS: Probabilistic models were used to simulate three dropout patterns (decreasing, constant, and increasing) after generation of multivariate normal data under wide scenarios of variability and correlations (CV ϭ 10% to 40%; ϭ 0.2 to 0.8). Monte Carlo simulations and mixed-effects models were carried out to obtain empirical sample sizes of the five designs using Schuirmann's TOST Procedure, under an 80% power and a 5% significance level, based on the equivalence criteria (80%, 125%). The five designs, cost function and calculation were previously described (Abstract PII-150, ASCPT 2005). RESULTS: D3ϫ2 is generally the best with dropouts. But D4ϫ4, often the best design without dropouts, becomes the second worst with dropouts. D4ϫ2 is the best when the screening cost is high and period cost does not vary. D2ϫ4 is s

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Author

PARASRAMPURIA, D; GELOTTE, C

Publisher

Nature Publishing Group; Wiley (Blackwell Publishing); Wiley-Blackwell; Wiley; Springer Science and Business Media LLC; Research Square (ISSN 0009-9236)

Published

2006

Language

EN

Field

Medicine (Health Sciences)