Stephen J. Ruberg

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We consider the problem of identifying a subgroup of patients who may have an enhanced treatment effect in a randomized clinical trial, and it is desirable that the subgroup be defined by a limited number of covariates. For this problem, the development of a standard, pre-determined strategy may help to avoid the well-known dangers of subgroup analysis. We(More)
  • S J Ruberg
  • Journal of biopharmaceutical statistics
  • 1995
A critical aspect of biomedical research is the characterization of the dose response relationship of a compound. This is true in laboratory experiments and clinical trials and pertains to efficacy, safety, and the resulting benefit/risk ratio. Presented here is Part I of this article, which deals with some clinical trial design issues surrounding dose(More)
  • S J Ruberg
  • Journal of biopharmaceutical statistics
  • 1995
The primary focus of this paper is to examine analysis strategies for parallel, randomized dose response studies with particular emphasis on identifying the minimum effective dose. Such studies have become a standard for drug development in the pharmaceutical industry. Particular attention is paid to ANOVA followed by multiple comparison procedures with(More)
The primary goal of this investigation was to describe the effect of terfenadine on the QT interval corrected for heart rate (QTc) of the scalar electrocardiogram (ECG). The design was double-blind, four-period crossover, dose escalation, which involved 28 normal healthy volunteers and 28 patients with stable cardiovascular disease. At baseline, the normal(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)
Enoximone possesses both positive inotropic and vasodilatory activities and may be useful in the treatment of patients with congestive heart failure (CHF). In all animal species investigated (rat, dog, monkey and man), the major urinary metabolite is the sulfide oxidation product (sulfoxide); very little unchanged drug appears in urine. Both in vitro and in(More)
BACKGROUND The genomics revolution is still in its infancy, and there is much to learn about how to transform biological knowledge into useful medicines to further public health. At the bedside, we are asking how and why individual patients respond to different drug treatments in different ways. In addition to genetic mechanisms, there are many clinical(More)
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)
The effects of enoximone (MDL 17,043) and 3-isobutyl-1-methylxanthine (IBMX) on developed tension, blood flow, and cyclic nucleotide levels were investigated in the isolated blood-perfused dog papillary muscle preparation. Intraarterial infusion of each agent, over 15 s, in doses ranging from 0.001 to 3 mg, produced a dose-dependent positive inotropic(More)