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Comparison of Designs for Response Surface Models with Random Block Effects

admin — Mon, 08 Mar 2010 12:55:27 +0000

Comparison of Designs for Response Surface Models with Random Block Effects
Sourish Saha and André Khuri
Published in Journal of Quality Technology and Quantitative Management, 2009, 6 (3), 219–234
Abstract: The purpose of this article is to compare designs for response surface models with a random block effect. To assess the quality of prediction associated with a [...]

Spatiotemporal regulation of the cough motor pattern

admin — Mon, 08 Mar 2010 12:55:27 +0000

Spatiotemporal regulation of the cough motor pattern
Cheng Wang, Sourish Saha, Melanie Rose, Paul Davenport and Donald Bolser
Published in Cough, 2009, 5-12
Abstract: The purpose of this study was to identify the spatiotemporal determinants of the cough motor pattern. We speculated that the spatial and temporal characteristics of the cough motor pattern would be regulated separately. [...]

Incomplete and Enriched Data Analysis and Sensitivity Analysis

admin — Mon, 08 Mar 2010 12:55:27 +0000

Incomplete and Enriched Data Analysis and Sensitivity Analysis
Geert Molenberghs (Discussant: James Roger)
Presented at DIA Statistics SIAC, VJC, January 13, 2010

Effects of unstratified and centre-stratified randomization in multi-centre clinical trials

admin — Mon, 08 Mar 2010 12:55:27 +0000

Effects of unstratified and centre-stratified randomization in multi-centre clinical trials
Vladimir Anisimov
Published in Pharmaceutical Statistics, 2010 (early view)
Abstract: This paper deals with the analysis of randomization effects in multi-centre clinical trials. The two randomization schemes most often used in clinical trials are considered: unstratified and centre-stratified block-permuted randomization. The prediction of the number of patients [...]

A review of synergy concepts of nonlinear blending and dose-reduction profiles

admin — Mon, 08 Mar 2010 12:55:27 +0000

A review of synergy concepts of nonlinear blending and dose-reduction profiles
John Peterson
Published in Frontiers of Bioscience, 2010, S2, 483–503
Abstract: This article presents a case-study review of synergy concepts of nonlinear blending and dose-reduction profiles. “Strong nonlinear blending” is a novel concept that provides a flexible paradigm for the assessment of combination drug [...]

The identification of a novel PDE4 inhibitor, EPPA-1, with improved therapeutic index using pica feeding in rats as a measure of emetogenicity

admin — Mon, 08 Mar 2010 12:55:26 +0000

The identification of a novel PDE4 inhibitor, EPPA-1, with improved therapeutic index using pica feeding in rats as a measure of emetogenicity
T. Gregg Davis, John J. Peterson, Jen-Pyng Kou, Elizabeth A. Capper-Spudich, Doug Ball, Anthony T. Nials, Joanne Wiseman, Yemisi E. Solanke, Fiona S. Lucas, Richard A. Williamson, Livia Ferrari, Paul Wren, Richard G. Knowles, [...]

The Impact of the Pneumococcal Conjugate Vaccine on Antimicrobial Resistance in the United States Since 1996: Evidence for a Significant Rebound by 2007 in Many Classes of Antibiotics

admin — Mon, 08 Mar 2010 12:55:26 +0000

The Impact of the Pneumococcal Conjugate Vaccine on Antimicrobial Resistance in the United States Since 1996: Evidence for a Significant Rebound by 2007 in Many Classes of Antibiotics
Robertino Mera, Linda Miller, Heather Amrine-Madsen, and Daniel F. Sahm
Published in Microbial Drug Resistance, 2009, 15 (4), 261-268
Abstract:
Background: The impact of the introduction of the pneumococcal [...]

What Your ICH Q8 Design Space Needs: A Multivariate Predictive Distribution

admin — Mon, 08 Mar 2010 12:55:26 +0000

What Your ICH Q8 Design Space Needs: A Multivariate Predictive Distribution
John Peterson
Published in Pharmaceutical Manufacturing, 2009
Abstract: The ICH Q8 core definition of design space is by now somewhat familiar: “The multidimensional combination and interaction of input variables (e.g., material attributes) and process parameters that have been demonstrated to provide assurance of quality” [1]. This definition [...]

A Bayesian Reliability Approach to Multiple Response Optimization with Seemingly Unrelated Regression Models

admin — Mon, 08 Mar 2010 12:55:26 +0000

A Bayesian Reliability Approach to Multiple Response Optimization with Seemingly Unrelated Regression Models
John Peterson, Guillermo Miró-Quesada and Enrique del Castillo
Published in Journal of Quality Technology and Quantitative Management, 2009, 6 (4), 353–369
Abstract: This paper presents a Bayesian predictive approach to multiresponse optimization experiments. It generalizes the work of Peterson [33] in two ways that [...]

A Bayesian Design Space Approach To Robustness and System Suitability for Pharmaceutical Assays and Other Processes

admin — Mon, 08 Mar 2010 12:55:26 +0000

A Bayesian Design Space Approach To Robustness and System Suitability for Pharmaceutical Assays and Other Processes
John Peterson and Mohammad Yahyah
Published in Statistics in Biopharmaceutical Research, 2009, 1 (4), 441–449
Abstract: The ICH Q2 (R1) Guidance on Validation of Analytical Procedures states that a robustness assessment for an analytical method should provide “an indication of [...]