Stephen J. Ruberg

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Data from 5 atomoxetine trials in pediatric outpatients with attention-deficit/hyperactivity disorder (ADHD) were divided into training and validation data sets to develop models predicting atomoxetine treatment response, using changes in individual ADHD Rating Scale (ADHD-RS) items early in treatment. Treatment response was predicted after 1 week by a > or(More)
Testing the equality of the area under a curve (AUC) for different dose groups is frequently done in pharmacokinetic research. Equality of AUCs is one indicator of bioequivalence. When the experimental unit must be sacrificed to obtain a response, AUC can be simply estimated using a linear combination of response means at various time points. The(More)
OBJECTIVE Identify the optimal magnitude of response to antipsychotic medication at various early time points that best predicts subsequent non-response at 8 weeks. METHODS Data were pooled from 5 randomized, double-blind clinical trials of atypical antipsychotics in the treatment of schizophrenia and related disorders (n=1137 moderately-to-severely ill;(More)
BACKGROUND To identify a simple decision tree using early symptom change to predict response to atypical antipsychotic therapy in patients with (Diagnostic and Statistical Manual, Fourth Edition, Text Revised) chronic schizophrenia. METHODS Data were pooled from moderately to severely ill patients (n = 1494) from 6 randomized, double-blind trials (N =(More)
Analyses of dose response studies should separate the question of the existence of a dose response relationship from questions of functional form and finding the optimal dose. A well-chosen contrast among the estimated effects of the studied doses can make a powerful test for detecting the existence of a dose response relationship. A contrast-based test(More)
(ADaM) in meeting submission data requirements are next described. Finally, this article discusses implementation alternatives for sponsors , future directions, and the potential benefit of current projects to improve the submission process. The Clinical Data Interchange Standards Consortium (CDISC) began in 1997 as a grassroots effort among individuals(More)
Dose-response studies with multiple endpoints can be formulated as closed testing or partition testing problems. When the endpoints are primary and secondary, whether the order in which the doses are to be tested is pre-determined or sample determined lead to different partitioning of the parameter space corresponding to the null hypotheses to be tested. We(More)
The explosion of research in the life sciences has cre­ ated the need for new mathematical theories, statisti­ cal methods, and computational algorithms with which to draw knowledge from the rapidly accumulat­ ing data. This need offers a great opportunity and challenge for the mathematical sciences. But to be successful, mathematicians and statisticians(More)
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