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PhUSE proceedings: Statistics and Pharmacokinetics, 82 papers

Pharmaceutical Users Software Exchange 2016   October 9-12, 2016 - Barcelona, Spain

Statistics and Pharmacokinetics Programming
tweet!  Standard Methods for Analysis and Reporting of VAS or NRS Derived Pain Relief Response Scores
  James R. Johnson, Flexion Therapeutics, Inc., Cary, NC USA
Keywords: Statistical Methods
Pages: 14 Size: 319 Kb    Download the presentationdownload (.pdf, 442 Kb)
tweet!  Probability plots as an instrument for comparing distributions
  Holger Langkabel, Roche, Basel, Switzerland
Keywords: Q-Q plots data visualization non-parametric methods
Pages: 9 Size: 397 Kb    Download the presentationdownload (.pdf, 666 Kb)
Best Presentation
tweet!  Upstream with your statistician and a data visualisation paddle
  Nick Cowans, Veramed, Twickenham, United Kingdom
Keywords: Data cleaning Data management Visual tools
Pages: 6 Size: 239 Kb    Download the presentationdownload (.pdf, 2050 Kb)
tweet!  Multiplicity Issues in Clinical Trials-Look at it with a magnifying glass!
  Madhusudhan Bandi, Hyderabad, India
Keywords: Multiplicity False positive rate Family wise error rate False discovery rate Hypothesis Alpha Power clinical
Pages: 6 Size: 578 Kb    Download the presentationdownload (.pdf, 140 Kb)
tweet!  Using graphics to review and present PK/PD data for maximum impact
  Md. Rajwanur Rahman, Shafi Consultancy Bangladesh; Shafi Chowdhury, Shafi Consultancy Ltd.; Marco Ackermann, Shafi Consultancy Ltd.
Keywords: PK/PD Graphics NONMEM
Pages: 9 Size: 550 Kb 

Pharmaceutical Users Software Exchange 2015   October 11-14, 2015 - Vienna, Austria

Statistics and Pharmacokinetics
tweet!  Programming Strategically for PK/PD Data
  Grace Lu, AstraZeneca
Pages: 8 Size: 87 Kb    Download the presentationdownload (.pdf, 1213 Kb)
Best Presentation
tweet!  Adjusting Long-term Efficacy Estimates when Patients Cross Over to Experimental Treatment
  Sabine Lauer, Dr. Lauer Research
Pages: 11 Size: 324 Kb    Download the presentationdownload (.pdf, 679 Kb)
tweet!  How to Reduce Bias in the Estimates of Count Data Regression
  Ashwini Joshi, Cytel, Sumit Singh, Cytel
Keywords: Count data Firth's method Bias reduction Proc LogXact
Pages: 10 Size: 474 Kb    Download the presentationdownload (.pdf, 467 Kb)
tweet!  Establish the Maximum Tolerated Dose in Phase 1 Trials Using the 3+3 Method
  Anup Pillai, Cytel
Keywords: 3+3 design Dose escalation
Pages: 12 Size: 208 Kb    Download the presentationdownload (.pdf, 625 Kb)
tweet!  Facing Your Fear of the Unknown- Handling Missing Data
  Amanda Reilly, ICON
Keywords: Imputation missing data
Pages: 7 Size: 219 Kb    Download the presentationdownload (.pdf, 1057 Kb)
A Simple and Novel Approach for the Assessment of Clinical Pharmacokinetics (Fast-track PK Analysis)
  Ramanatha Saralaya, Cytel; Nand Kishore Rawat, Cytel
Keywords: clinical
  Download the presentationdownload (.pdf, 1925 Kb)
tweet!  Bias Reduction in Observational Cohort Studies - Obtaining Matched Cohorts Using Propensity Scores
  Shelley Fordred, Savvy Stats; Victor Kiri, FV & JK Consulting; Knut Mueller, UCB
Keywords: Propensity Scores Confounding PROC LOGISTIC Matching
Pages: 8 Size: 555 Kb    Download the presentationdownload (.pdf, 3680 Kb)

Pharmaceutical Users Software Exchange 2014   October 12-15, 2014 - London, United Kingdom

Statistics and Pharmacokinetics
tweet!  Checking Symmetry in Predefined Time Assessments
  Antonio Nieto, PharmaMar; José Luis Jiménez Moro, PharmaMar
Pages: 9 Size: 104 Kb    Download the presentationdownload (.pdf, 338 Kb)
tweet!  Inverse Probability of Censoring Weighting for Selective Crossover in Oncology Clinical Trials
  José Luis Jiménez Moro, PharmaMar; Javier Gómez Garcia, PharmaMar
Keywords: clinical
Pages: 5 Size: 342 Kb    Download the presentationdownload (.pdf, 566 Kb)
Best Presentation
tweet!  Small Sample Bayesian Factor Analysis
  Dirk Heerwegh, Business & Decision Life Sciences
Pages: 18 Size: 318 Kb    Download the presentationdownload (.pdf, 401 Kb)
tweet!  Multiple Imputation: Better than Single Imputation in Pain Studiees
  Ashik Chowdhury, Cytel
Pages: 12 Size: 955 Kb    Download the presentationdownload (.pdf, 838 Kb)
tweet!  Analysis of Time to FDA Medwatch Safety Alert for Therapeutic Monoclonal Antibodies
  Pavla Kadlecová, Aprova; Vid Stanulovic, Aprova; Ladislav Pecen, International Clinical Research Centre, St. Ann's Hospital
Keywords: Monoclonal antibody safety alert pharmacovigilance FDA Medwatch Kaplan-Meier
Pages: 5 Size: 181 Kb    Download the presentationdownload (.pdf, 647 Kb)
tweet!  Biomarker as Essential Part of Clinical Development
  Renuka Chinthapally, Cytel
Keywords: clinical
Pages: 7 Size: 422 Kb    Download the presentationdownload (.pdf, 653 Kb)
tweet!  Examining the Tests Behind Survival Curves
  Hans-Dieter Spies, InVentiv Health Clinical
Pages: 7 Size: 81 Kb    Download the presentationdownload (.pdf, 741 Kb)
tweet!  Forest Plot: W**3 + H**2 What, Why, When and How to Generate and How to Interpret
  Petra Van Wetten, Novartis
Pages: 10 Size: 1340 Kb    Download the presentationdownload (.pdf, 2879 Kb)

Pharmaceutical Users Software Exchange 2013   October 13-16, 2013 - Brussels, Belgium

Statistics and Pharmacokinetics
tweet!  Posch-Bauer Seamless Test with SAS
  Antonio Nieto, PharmaMar; Javier Gómez, PharmaMar
Pages: 4 Size: 115 Kb    Download the presentationdownload (.pdf, 414 Kb)
tweet!  Bayesian Statistics: Concept and Bayesian Capabilities in SAS
  Mark Janssens, I-BioStat, Hasselt University
Pages: 15 Size: 524 Kb    Download the presentationdownload (.pdf, 16582 Kb)
tweet!  Using PROC GENMOD to Analyses Ratio to Placebo in Change of Dactylitis
  Imgard Hollweck, UCB BioSciences GbmH
Keywords: Genmod binomial odds ratio dactylitis
Pages: 9 Size: 554 Kb    Download the presentationdownload (.pdf, 1171 Kb)
tweet!  Multivariate Bioequivalence
  Shital Agawane, Cytel; Sanjukta Roy, Cytel
Keywords: Bioequivalence Multivariate Approach Quadratic Form Empirical Power Cholesky Decomposition Simulation
Pages: 8 Size: 310 Kb    Download the presentationdownload (.pdf, 990 Kb)
tweet!  Computation of Cls for Binomial Proportions in SAS and its Practical Difficulties
  Jose Abraham, Kreara Solutions Pvt Ltd
Keywords: Clopper-Pearson Exact Binomial Proportions PROC FREQ
Pages: 8 Size: 165 Kb    Download the presentationdownload (.pdf, 2677 Kb)
tweet!  Computing the 'Competing Risks' - Modeling Survival Data with Competing Risk Events using SAS® Macros
  Swapna Deshpande, Cytel
Keywords: macro
Pages: 10 Size: 515 Kb    Download the presentationdownload (.pdf, 767 Kb)
Best Presentation
tweet!  Extensions of Cox Model for Non-Proportional Hazards Purpose
  Jadwiga Borucka, Parexel
Keywords: Cox model non-proportional hazards survival analysis
Pages: 10 Size: 567 Kb    Download the presentationdownload (.pdf, 537 Kb)
tweet!  Determination of Body Sway area by Fourier Analysis of its Contour
  Thomas Wollseifen, i3 Pharmaceutical Services GmbH
Keywords: Posturography Body Sway PROC SPECTRA PCA convex hull concave hull
Pages: 7 Size: 4801 Kb    Download the presentationdownload (.pdf, 6719 Kb)
tweet!  Lexis Expansion - Age-at-Risk Adjustment for Survival Analysis
  Lai San Hong, Redsen Ltd; Sarah Lewington, Clinical Trial Service Unit and Epidemiological Studies Unit of the University of Oxford
Keywords: Lexis Age-at-Risk Cox Proportional Hazard Model
Pages: 5 Size: 392 Kb 
tweet!  Central Statistical Monitoring in Action
  Francois Torche, CluePoints; Erik Doffagne, CluePoints
Pages: 6 Size: 335 Kb    Download the presentationdownload (.pdf, 4565 Kb)

Pharmaceutical Users Software Exchange 2012   October 14-17, 2012 - Budapest, Hungary

Statistics and Pharmacokinetics
tweet!  A Supplement to the SAS Survial Guide- Nonparametric Regression
  Karl-Ernst Siegler, CRS-Clinical Research Services
Pages: 8 Size: 355 Kb    Download the presentationdownload (.pdf, 1213 Kb)
tweet!  Misinterpretation of Statistics - An Introduction
  John Salter, Cerafor
Pages: 9 Size: 1590 Kb    Download the presentationdownload (.pdf, 1590 Kb)
tweet!  Bootstrap Simulations to Estimate Overall Survival Based on the Distribution of a Historical Control
  Antonio Nieto, PharMar; Javier Gómez, PharMar
Pages: 7 Size: 189 Kb    Download the presentationdownload (.pdf, 642 Kb)
tweet!  Training Statistical Programmers on SAP Review Skills
  Sascha Ahrweiler, UCB BioSciences GmbH
Keywords: SAP Review Training Statistical Programmers
Pages: 7 Size: 130 Kb    Download the presentationdownload (.pdf, 1472 Kb)
tweet!  Time Series Modeling of Vaccine Efficiency using a JMP10 Add-in
  Robert Eric Huisden, OCS Biometric Support
Pages: 5 Size: 312 Kb    Download the presentationdownload (.pdf, 3032 Kb)
tweet!  Quartiles within SAS Procedures
  Jorine Putter, Quantitate; Liz Faber, Quanticate
Keywords: Quartiles quartile qntldef pctldef Q1 Q2 Q3 percentiles percentile SAS 25th percentile 50th percentile 75th percentile median
Pages: 7 Size: 140 Kb    Download the presentationdownload (.pdf, 997 Kb)
tweet!  Multicollinearity Diagnostics in Statistical Modeling and Remedies to Deal with it Using SAS
  Harshada Joshi, Cytel Statistical Software & Services Pvt. Ltd; Swapna Deshpande, Cytel Statistical Software & Services Pvt. Ltd
Keywords: Multicollinearity Ridge Regression Principal component
Pages: 12 Size: 302 Kb    Download the presentationdownload (.pdf, 842 Kb)
Best Presentation
tweet!  Estimating Terminal Half Life by Non-Compartmental Methods with Some Data Below the Limit of Quantification
  Jochen Müller-Cohrs, CSL Behring GmbH
Keywords: Pharmacokinetic non-compartmental analysis quantification limit
Pages: 6 Size: 178 Kb    Download the presentationdownload (.pdf, 2135 Kb)

Pharmaceutical Users Software Exchange 2011   October 9-12, 2011 - Brighton, United Kingdom

Statistics and Pharmacokinetics
tweet!  Estimation of relative potency in a 4-point parallel line assay
  Stefano Vezzoli, CROS NT Srl
Keywords: relative potency potency ratio parallel line assay equivalence finney asthma
Pages: 11 Size: 352 Kb 
tweet!  Different Methods of Calculating Body Sway Area
  Thomas Wollseifen, i3
Keywords: Body Sway Principal Component Analysis Convex hull Circle Area Posturography
Pages: 24 Size: 357 Kb    Download the presentationdownload (.ppt, 3745 Kb)
tweet!  Use of early longitudinal viral load as a surrogate to the virologic endpoint in Hepatitis C
  Igwebuike Enweonye, Business & Decision Life Sciences
Pages: 12 Size: 1217 Kb    Download the presentationdownload (.ppt, 2590 Kb)
tweet!  Embedding equivalence t-test results in Bland Altman Plots visualising rater reliability
  Jim Groeneveld, OCS Consulting
Keywords: rater reliability equivalence t-test Bland Altman Plot
Pages: 5 Size: 382 Kb    Download the presentationdownload (.ppt, 419 Kb)
Best Presentation
tweet!  An Animated Guide: An Introduction to Latent Class Clustering in SAS
  Russell Lavery, Independent Contractor
Pages: 19 Size: 918 Kb 
tweet!  Bayesian hypothesis testing for proportions
  Antonio Nieto, PharmaMar; Sonia Extremera, PharmaMar; Javier Gómez, PharmaMar
Pages: 6 Size: 304 Kb    Download the presentationdownload (.ppt, 928 Kb)

Pharmaceutical Users Software Exchange 2010   October 14-17, 2010 - Berlin, Germany

Statistics and Pharmacokinetics
An Animated Guide: An introduction to Poisson Regression
  Russ Lavery, Independent
tweet!  Using Data and Text Mining to drive Innovation
  David Smith, SAS Institute
Pages: 6 Size: 242 Kb    Download the presentationdownload (.ppt, 13930 Kb)
Best Presentation
tweet!  Inference for the Location Shift in 3x3 Crossover Studies: the Median-Scaling Method
  Stefano Vezzoli, CROS NT
Keywords: tmax nonparametric crossover median scaling
Pages: 5 Size: 145 Kb    Download the presentationdownload (.ppt, 1550 Kb)
tweet!  Assesment of Cox Proportional Hazard Model Adequacy Using PROC PHREG and PROC GPLOT
  Jadwiga Borucka, Quanticate
Pages: 13 Size: 929 Kb    Download the presentationdownload (.pdf, 605 Kb)
tweet!  Useful Tips for Analysis of Variance (ANOVA) in Multicentre, Placebo Controlled Clinical Trials
  Joanna Romaniuk, Quanticate
Keywords: clinical
Pages: 12 Size: 349 Kb    Download the presentationdownload (.ppt, 5265 Kb)
tweet!  Getting your data in good shape for Non Linear Mixed Effects Modeling
  Vincent Buchheit, Novartis
Keywords: nonmem modeling and simulation PK PD pharmacokinetic pharmacodynamic outliers data consistency missing data open entry fields in CRF
Pages: 4 Size: 248 Kb    Download the presentationdownload (.ppt, 16163 Kb)
tweet!  Waterfall plots: A beautiful and easy way of showing a whole picture of an interesting outcome
  Antonio Nieto, PharmaMar; Javier Gómez, PharaMar
Pages: 8 Size: 43 Kb    Download the presentationdownload (.ppt, 499 Kb)
tweet!  BeST- BIOEQUIVALENCE STUDY TEMPLATE
  Pekka Heikkila, StatFinn
Keywords: pharmacokinetics PK bioequivalence ODS RTF CDISC SDTM ISO 8601 SAS
Pages: 9 Size: 1500 Kb    Download the presentationdownload (.ppt, 16178 Kb)

Pharmaceutical Users Software Exchange 2009   October 19-21, 2009 - Basel, Switzerland

Statistics and Pharmacokinetics
tweet!  An Animated Guide: Matching Test and Control Subjects
  Russ Lavery, Independent Contractor
Pages: 21 Size: 164 Kb 
Best Presentation
tweet!  Comparing Kaplan-Meier curves - what are the (SAS) options?
  Rob Allis, Amgen
Pages: 5 Size: 186 Kb 
tweet!  The role of the statistician in data monitoring committees
  Fritz Schindel, Accovion
Pages: 28 Size: 135 Kb 
tweet!  An Application of SAS in Model Based Drug Development
  Imelda Parker, Quintiles; Michael O'Kelly, Quintiles
Pages: 4 Size: 73 Kb 
tweet!  On the use of spreadsheets for statistical analysis
  Martin Gregory, Merck Serono
Keywords: spreadsheet excel statistical analysis
Pages: 7 Size: 110 Kb 

Pharmaceutical Users Software Exchange 2008   October 12-15, 2008 - Manchester, United Kingdom

Statistics and Pharmacokinetics
tweet!  Exchange of Information for the Statistical Analysis and Reporting of PK Parameter Data
  Ann Cuijpers, J&JPRD; Sarah Rusch, J&JPRD; Iris Van de Vliet, J&JRPD
Pages: 2 Size: 87 Kb 
Best Presentation
tweet!  Evaluation of Diagnostic Agents: a SAS® Macro for Sample Size Estimation Using Exact Methods
  Stefano Vezzoli, CROS NT
Keywords: sample size diagnostic test exact method macro binomial proportion
Pages: 8 Size: 360 Kb 
tweet!  A gentle introduction to Survival Analysis
  Angelo Tinazzi, SENDO Tech S.r.l.; Martin Scott, Numerous Limited; Anna Compagnoni, SENDO Tech S.r.l.
Pages: 13 Size: 255 Kb 
tweet!  How to produce Forrest-plots with PROC GPLOT and Annotate facility
  Laetitia Lemoine Le Halpert, Quintiles
Pages: 8 Size: 108 Kb 
tweet!  Concepts and Ideas for Developing and Maintaining a Utility Toolbox of SAS Statistical Procedures
  David Carr, ICON Clinical Research
Keywords: SAS PROC FREQ CHI-SQUARE PROC MIXED PROC NPAR1WAY KRUSKAL-WALLIS PROC LIFETEST KAPLAN-MEIER ANOVA
Pages: 6 Size: 157 Kb 
tweet!  Statistically guided review of safety data in clinical trials
  Michael O'Connell, ITIBCO Spotfire; Harry Southworth, AstraZeneca
Keywords: Bayesian S-PLUS safety open source WinBugs clinical
Pages: 12 Size: 458 Kb 
tweet!  A Collection of SAS Macros to Calculate Odds Ratios using Spline Regression
  Martin Gregory, Merck Serono
Keywords: spline regression macro odds ratio
Pages: 9 Size: 146 Kb 

Pharmaceutical Users Software Exchange 2007   October 8-10, 2007 - Lisbon, Portugal

Statistics and Pharmacokinetics
tweet!  Using SAS to perform a stratified t-test
  John Salter, Oxford Pharmaceutical Sciences Ltd, Oxford, UK
Pages: 7 Size: 80 Kb 
tweet!  Reporting of NONMEM Models using S-PLUS
  Richard Pugh, Mango Solutions
Pages: 7 Size: 272 Kb 
tweet!  Implementation of bootstrapping in a replicative bioequivalence study with a highly variable drug
  Feryal Tanriverdio, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany; Arne Ring, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany
Pages: 11 Size: 391 Kb 
tweet!  Application of the ARRAY statement to create ESTIMATE and CONTRAST statements in statistical PROCEDURES: a case study.
  Roel Straetemans, Janssen Pharmaceutical, Beerse, Belgium; Franky De Cooman, GBSC, Gent, Belgium
Keywords: array
Pages: 10 Size: 90 Kb 
tweet!  Consideration of Endogenous Backgrounds in Pharmacokinetic Analyses
  Fritz Schindel, Accovion, Marburg, Germany
Keywords: PK model biologic compounds endogenous background simulation
Pages: 10 Size: 51 Kb 
Best Presentation
tweet!  Data Mining in the Clinical Research Environment
  Dave Smith, SAS, Marlow, UK
Keywords: clinical
Pages: 7 Size: 153 Kb 
tweet!  Bayesian Modeling with S-PLUS and the S+flexBayes Library
  Andrew Jack, Insightful Corporation, Basingstoke, UK; Dawn Woodard, Insightful Corporation, RTP, North Carolina, US; Joel Hoffman, Insightful Corporation, Basel, Switzerland; Michael O'Connell, Insightful Corporation, RTP, North Carolina, US
Keywords: Bayes S-PLUS BUGS safety
Pages: 11 Size: 416 Kb 

Pharmaceutical Users Software Exchange 2006   October 9-11, 2006 - Dublin, Ireland

Statistics and Pharmacokinetics
tweet!  A tour through PROC ROBUSTREG
  Michael O'Kelly, Quintiles Ireland Ltd
Pages: 8 Size: 248 Kb 
tweet!  Proc Mixed - Trials and Tribulations
  Shelley Fordred, GlaxoSmithKline
Keywords: Proc Mixed Pharmacokinetics Cmax Random Effects
Pages: 7 Size: 340 Kb 
tweet!  Statistics and Pharmacokinetics in Clinical Pharmacology Studies
  Amy Newlands, GlaxoSmithKline
Keywords: SAS Pharmacokinetics dose proportionality First Time in Human Repeat Dose clinical
Pages: 8 Size: 388 Kb 
tweet!  Having Confidence in non-parametric data
  John Salter, Oxford Pharmaceutical Sciences
Pages: 8 Size: 302 Kb 
tweet!  (Sample) Size DOES Matter
  John Salter, Oxford Pharmaceutical Sciences
Pages: 10 Size: 360 Kb 
tweet!  "Self-validating" data
  Christof Binder, BIOP, Biometrical Practice; Dante diTommaso, F. Hoffmann-La Roche Ltd
Keywords: Data validation
Pages: 7 Size: 277 Kb 
Best Presentation
tweet!  Analysis of incomplete two-period crossover trials with SAS PROC MIXED
  Jochen Müller-Cohrs, Accovion
Keywords: Crossover missing data mixed models repeated measurements
Pages: 8 Size: 696 Kb 

Pharmaceutical Users Software Exchange 2005   October 10-12, 2005 - Heidelberg, Germany

Statistics & Pharmacokinetics
Best Presentation
tweet!  Power calculation of non-inferiority trials assuming poisson distributions
  Corinna Miede, Accovion; Jochen Müller-Cohrs, Accovion
Keywords: non-inferiority poisson distribution power type I error rate
Pages: 11 Size: 228 Kb 
tweet!  A Practical Introduction to the Bootstrap Using the SAS System
  Nancy Barker, Oxford Pharmaceutical Sciences
Keywords: bootstrap SAS confidence intervals
Pages: 17 Size: 97 Kb 
tweet!  Splendida fugilente oculi, e.g. dummy randomization lists to more than designed patient profiles
  Magnus Mengelbier, Amgen
Pages: 5 Size: 170 Kb 
tweet!  A case study to demonstrate the recommended approach from NICE to assess uncertainty in cost effectiveness models.
  Karen Ooms, Head of Statistical Consultancy, Statwood.; Bevan House, Bancroft Court, Hitchin, Herts, SG5 1LH
Pages: 1 Size: 9 Kb 
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