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POD-10.11: Long-term Efficacy of Combination Therapy with the Dual 5-α Reductase Inhibitor Dutasteride and the α-Blocker Tamsulosin in the Treatment of Benign Prostatic Hyperplasia: 4-year Results from the Randomized, Double-blind, CombAT Trial

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Urology 2009年第4期74卷 S33-S34页

作者： C. Roehrborn J. Barkin B. Morrill L. Black R.P. Gagnier Dept. of Urology UT Southwestern Medical Center Dallas Texas USA Dept. of Urology University of Toronto Toronto Ontario Canada Biostatistics and Programming GlaxoSmithKline Research Triangle Park North Carolina USA Global Health Outcomes GlaxoSmithKline Research Triangle Park North Carolina USA Clinical Development GlaxoSmithKline Research Triangle Park North Carolina USA

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MP-06.17: Efficacy and safety of dutasteride, tamsulosin and the combination in Asian men: 4-year results from the randomised, double-blind, CombAT trial

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Urology 2009年第4期74卷 S74-S74页

作者： Chung, B.H. Roehrborn, C. Siami, P. Major-Walker, K. Wilson, T. Montorsi, F. Department of Urology Yonsei University Health System Seoul Korea Department of Urology UT Southwestern Medical Center Dallas Texas Welborn Clinic Evansville Indiana USA Clinical Development GlaxoSmithKline Research Triangle Park North Carolina USA Biostatistics and Programming GlaxoSmithKline Research Triangle Park North Carolina USA Department of Urology Universita Vita Salute San Raffaele Milan Italy

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Correction

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Statistics in Medicine 2007年第27期26卷

作者： Yujun Wu Weichung J. Shih Dirk F. Moore Biostat and Programming Sanofi-Aventis Bridgewater NJ U.S.A. Department of Biostatistics University of Medicine and Dentistry of New Jersey Piscataway NJ U.S.A. Department of Biometrics University of Medicine and Dentistry of New Jersey Piscataway NJ U.S.A.

‘Estimating a survival curve with unlinked entry and failure times’, by Yujun Wu, Weichung J. Shih and Dirk F. Moore ( Statistics in Medicine 2007; 26 :3624–3638). (1) Equation (5) on page 3629 reads which should r...

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Phase specific analysis of herpes zoster associated pain data: a new statistical approach

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STATISTICS IN MEDICINE 2006年第2期25卷 359-360页

作者： Kay, R PAREXEL WW Head Biostatistics & Programming

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Ranitidine (Zantac®) syrup versus ranitidine effervescent tablets (Zantac® EFFERdose®) in children: A single-center taste preference study

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Pediatric Drugs 2006年第4期8卷 265-270页

作者： Ameen, Vanessa Z. Pobiner, Bonnie F. Giguere, Gregory C. Carter, Eric G. Clinical Pharmacology and Discovery Medicine Research and Development GlaxoSmithKline Research Triangle Park NC United States Gastroenterology Medicine Development Center GlaxoSmithKline Research Triangle Park NC United States Department of Biostatistics and Programming GlaxoSmithKline Research Triangle Park NC United States GlaxoSmithKline Research Triangle Park NC 27709 5 Moore Drive United States

Background: The histamine H2 receptor antagonist ranitidine is US FDA-approved for the treatment of gastroesophageal reflux disease and healing of erosive esophagitis in children ≥1 month of age. A low-dose strength ...

Background: The histamine H₂ receptor antagonist ranitidine is US FDA-approved for the treatment of gastroesophageal reflux disease and healing of erosive esophagitis in children ≥1 month of age. A low-dose strength of ranitidine is now available in a citrus-flavored 25mg effervescent tablet (dissolved in 5mL of water);this formulation was developed to facilitate use in infants and smaller children. Ranitidine syrup is available in a peppermint-flavored 15 mg/mL formulation. Objective: To compare taste preferences for ranitidine (Zantac®) syrup and ranitidine effervescent tablets dissolved in water (Zantac® EFFERdose®) in healthy children aged 4-8 years and their adult caregivers. Study Design and Methods: A randomized, single-blind, crossover, taste test trial was conducted in 102 children and 102 parents/legal guardians. All subjects received a single 45mg dose of each formulation. After tasting both preparations children were asked: "Now that you have tasted both medicines, which one of these medicines do you think tastes better?" Adults were asked four questions to assess whether they would administer the medication to the children. Results: Seventy-one percent (72/102) of the children preferred the taste of the ranitidine effervescent tablets compared with 29% (30/102) who preferred the syrup (p < 0.001). The majority of adults (71%) responded that they would prefer to administer the effervescent formulation based on taste. Adverse events consistent with product labeling were mild and were reported in four children and three adults: headache (n = 3), drowsiness (n = 1), abdominal pain/cramps (n = 2), and bloating/gas (n = 1). Conclusion: The taste of the ranitidine effervescent formulation dissolved in water is preferred over the ranitidine syrup. Better taste acceptance may facilitate ease of administration and compliance in pediatric patients. © 2006 Adis Data Information BV. All rights reserved.

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MP-09.09

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Urology 2006年 68卷 108-109页

作者： C. Roehrborn M. Marberger E. Wolford T. Wilson University of Texas Southwestern Medical Center Dallas TX USA University of Vienna Vienna Austria Urology Clinical Development GlaxoSmithKline Research Triangle Park NC USA Biostatistics and Programming GlaxoSmithKline Research Triangle Park NC USA

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On some "disadvantages" of the population approach

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AAPS Journal 2005年第2期7卷 E374-E382页

作者： Nedelman, Jerry R. Biostatistics and Statistical Programming Novartis Pharmaceuticals East Hanover NJ 07936 One Health Plaza United States

In a seminal article on population pharmacokinetic modeling, researchers demonstrated how means and variances of pharmacokinetic parameters for a patient population could be inferred from sparse data collected under conditions of routine patient care. But they also identified 4 potential concerns about their methodology: unobserved confounding variables may bias the inferences;conditions under which data are collected may lead to inaccuracies of reporting or recording;correlations among important predictor variables may reduce statistical efficiency;and costs cannot be controlled by principles of study design. Experiences are reviewed that relate to these potential disadvantages. A method is presented for diagnosing the possible presence of confounding. A model is constructed and applied that captures the influences of data inaccuracies. An example of selecting from among correlated covariates is summarized. Finally, a methodology for optimal study design is reviewed and applied to an example. Copyright ©2003. All Rights Reserved.

关键词： Confounding Errors in variables Noncompliance Optimal design Variable selection

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What was the cause of Franklin Delano Roosevelt's paralytic illness?

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Journal of Medical Biography 2003年第4期11卷 232-240页

作者： Goldman, Armond S Schmalstieg, Elisabeth J Freeman, Daniel H Goldman, Daniel A Schmalstieg, Frank C Texas University of Texas Medical Branch in Galveston United States University of Texas Medical Branch in Galveston Texas United States Office of Biostatistics University of Texas Medical Branch Galveston Texas United States President of Expert Health Data Programming Inc.

In 1921, when he was 39 years of age, Franklin Delano Roosevelt contracted an illness characterized by: fever;protracted symmetric, ascending paralysis;facial paralysis;bladder and bowel dysfunction;numbness;and dysaesthesia. The symptoms gradually resolved except for paralysis of the lower extremities. The diagnosis at the onset of the illness and thereafter was paralytic poliomyelitis. Yet his age and many features of the illness are more consistent with a diagnosis of Guillain-Barré syndrome, an autoimmune polyneuritis. The likelihoods (posterior probabilities) of poliomyelitis and Guillain-Barré syndrome were investigated by Bayesian analysis. Posterior probabilities were calculated by multiplying the prior probability (disease incidence in Roosevelt's age group) by the symptom probability (likelihood of a symptom occurring in a disease). Six of eight posterior probabilities strongly favoured Guillain-Barré syndrome. © 2003, SAGE Publications. All rights reserved.

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Editorial

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Pharmaceutical Statistics 2003年第2期1卷

作者： Richard Kay Biostatistics and Programming PAREXEL International Ltd Navigation House 1 South Quay Drive Victoria Quays Sheffield S2 5SU UK

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Modeling Dose-Response Microarray Data in Early Drug Development Experiments Using R 1

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丛书名： Use R!

1000年

作者： Dan Lin Ziv Shkedy Daniel Yekutieli Dhammika Amaratunga Luc Bijnens

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