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Pharmaceutical Statistics Using SAS by Alex Dmitrienko,Christy Chuang-Stein,Ralph B. D'Agostino Pdf
Introduces a range of data analysis problems encountered in drug development and illustrates them using case studies from actual pre-clinical experiments and clinical studies. Includes a discussion of methodological issues, practical advice from subject matter experts, and review of relevant regulatory guidelines.
Pharmaceutical Statistics Using SAS by Ph Dmitrienko,Ph Chuang-Stein,Ralph D'Agostino Pdf
Pharmaceutical Statistics Using SAS: A Practical Guide offers extensive coverage of cutting-edge biostatistical methodology used in drug development and the practical problems facing today's drug developers. Written by well-known experts in the pharmaceutical industry Alex Dmitrienko, Christy Chuang-Stein, and Ralph D'Agostino, it provides relevant tutorial material and SAS examples to help readers new to a certain area of drug development quickly understand and learn popular data analysis methods and apply them to real-life problems. Step-by-step, the book introduces a wide range of data analysis problems encountered in drug development and illustrates them using a wealth of case studies from actual pre-clinical experiments and clinical studies. The book also provides SAS code for solving the problems. Among the topics addressed are these: drug discovery experiments to identify promising chemical compounds animal studies to assess the toxicological profile of these compounds clinical pharmacology studies to examine the properties of new drugs in healthy human subjects Phase II and Phase III clinical trials to establish therapeutic benefits of experimental drugs. Additional features include a discussion of methodological issues, practical advice from subject-matter experts, and review of relevant regulatory guidelines. Most chapters are self-contained and include a fair amount of high-level introductory material to make them accessible to a broad audience of pharmaceutical scientists. This book will also serve as a useful reference for regulatory scientists as well as academic researchers and graduate students.
Pharmaceutical Statistics Using SAS by Alex Dmitrienko,Christy Chuang-Stein,Ralph D'Agostino Pdf
Pharmaceutical Statistics Using SAS: A Practical Guide offers extensive coverage of cutting-edge biostatistical methodology used in drug development and the practical problems facing today's drug developers. Written by well-known experts in the pharmaceutical industry Alex Dmitrienko, Christy Chuang-Stein, and Ralph D'Agostino, it provides relevant tutorial material and SAS examples to help readers new to a certain area of drug development quickly understand and learn popular data analysis methods and apply them to real-life problems. Step-by-step, the book introduces a wide range of data analysis problems encountered in drug development and illustrates them using a wealth of case studies from actual pre-clinical experiments and clinical studies. The book also provides SAS code for solving the problems. Among the topics addressed are these: drug discovery experiments to identify promising chemical compounds animal studies to assess the toxicological profile of these compounds clinical pha
Analysis of Clinical Trials Using SAS by Alex Dmitrienko,Gary G. Koch Pdf
Analysis of Clinical Trials Using SAS®: A Practical Guide, Second Edition bridges the gap between modern statistical methodology and real-world clinical trial applications. Tutorial material and step-by-step instructions illustrated with examples from actual trials serve to define relevant statistical approaches, describe their clinical trial applications, and implement the approaches rapidly and efficiently using the power of SAS. Topics reflect the International Conference on Harmonization (ICH) guidelines for the pharmaceutical industry and address important statistical problems encountered in clinical trials. Commonly used methods are covered, including dose-escalation and dose-finding methods that are applied in Phase I and Phase II clinical trials, as well as important trial designs and analysis strategies that are employed in Phase II and Phase III clinical trials, such as multiplicity adjustment, data monitoring, and methods for handling incomplete data. This book also features recommendations from clinical trial experts and a discussion of relevant regulatory guidelines. This new edition includes more examples and case studies, new approaches for addressing statistical problems, and the following new technological updates: SAS procedures used in group sequential trials (PROC SEQDESIGN and PROC SEQTEST) SAS procedures used in repeated measures analysis (PROC GLIMMIX and PROC GEE) macros for implementing a broad range of randomization-based methods in clinical trials, performing complex multiplicity adjustments, and investigating the design and analysis of early phase trials (Phase I dose-escalation trials and Phase II dose-finding trials) Clinical statisticians, research scientists, and graduate students in biostatistics will greatly benefit from the decades of clinical research experience and the ready-to-use SAS macros compiled in this book.
SAS Programming in the Pharmaceutical Industry, Second Edition by Jack Shostak Pdf
This comprehensive resource provides on-the-job training for statistical programmers who use SAS in the pharmaceutical industry This one-stop resource offers a complete review of what entry- to intermediate-level statistical programmers need to know in order to help with the analysis and reporting of clinical trial data in the pharmaceutical industry. SAS Programming in the Pharmaceutical Industry, Second Edition begins with an introduction to the pharmaceutical industry and the work environment of a statistical programmer. Then it gives a chronological explanation of what you need to know to do the job. It includes information on importing and massaging data into analysis data sets, producing clinical trial output, and exporting data. This edition has been updated for SAS 9.4, and it features new graphics as well as all new examples using CDISC SDTM or ADaM model data structures. Whether you're a novice seeking an introduction to SAS programming in the pharmaceutical industry or a junior-level programmer exploring new approaches to problem solving, this real-world reference guide offers a wealth of practical suggestions to help you sharpen your skills. This book is part of the SAS Press program.
Common Statistical Methods for Clinical Research with SAS Examples, Third Edition by Glenn Walker,Jack Shostak Pdf
Glenn Walker and Jack Shostak's Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is a thoroughly updated edition of the popular introductory statistics book for clinical researchers. This new edition has been extensively updated to include the use of ODS graphics in numerous examples as well as a new emphasis on PROC MIXED. Straightforward and easy to use as either a text or a reference, the book is full of practical examples from clinical research to illustrate both statistical and SAS methodology. Each example is worked out completely, step by step, from the raw data. Common Statistical Methods for Clinical Research with SAS Examples, Third Edition, is an applications book with minimal theory. Each section begins with an overview helpful to nonstatisticians and then drills down into details that will be valuable to statistical analysts and programmers. Further details, as well as bonus information and a guide to further reading, are presented in the extensive appendices. This text is a one-source guide for statisticians that documents the use of the tests used most often in clinical research, with assumptions, details, and some tricks--all in one place. This book is part of the SAS Press program.
Applied Statistics in the Pharmaceutical Industry by Steven P. Millard,Andreas Krause Pdf
Providing a general guide to statistical methods used in the pharmaceutical industry, and illustrating how to use S-PLUS to implement these methods, the book explains why S-PLUS is a useful software package and discusses the results and implications of each particular application. It is targeted at graduates in biostatistics, statisticians involved in the industry as research scientists, regulators, academics, and/or consultants who want to know more about how to use S-PLUS and learn about other sub-fields within the industry, as well as statisticians in other fields who want to know more about statistical applications in the pharmaceutical industry.
Author : Carol I. Matthews,Brian C. Shilling Publisher : SAS Institute Page : 229 pages File Size : 40,5 Mb Release : 2008 Category : Computers ISBN : 9781599941288
Validating Clinical Trial Data Reporting with SAS by Carol I. Matthews,Brian C. Shilling Pdf
This indispensable guide focuses on validating programs written to support the clinical trial process from after the data collection stage to generating reports and submitting data and output to the Food and Drug Administration.
Implementing CDISC Using SAS by Chris Holland,Jack Shostak Pdf
For decades researchers and programmers have used SAS to analyze, summarize, and report clinical trial data. Now Chris Holland and Jack Shostak have updated their popular Implementing CDISC Using SAS, the first comprehensive book on applying clinical research data and metadata to the Clinical Data Interchange Standards Consortium (CDISC) standards. Implementing CDISC Using SAS: An End-to-End Guide, Revised Second Edition, is an all-inclusive guide on how to implement and analyze the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM) data and prepare clinical trial data for regulatory submission. Updated to reflect the 2017 FDA mandate for adherence to CDISC standards, this new edition covers creating and using metadata, developing conversion specifications, implementing and validating SDTM and ADaM data, determining solutions for legacy data conversions, and preparing data for regulatory submission. The book covers products such as Base SAS, SAS Clinical Data Integration, and the SAS Clinical Standards Toolkit, as well as JMP Clinical. Topics included in this edition include an implementation of the Define-XML 2.0 standard, new SDTM domains, validation with Pinnacle 21 software, event narratives in JMP Clinical, STDM and ADAM metadata spreadsheets, and of course new versions of SAS and JMP software. The second edition was revised to add the latest C-Codes from the most recent release as well as update the make_define macro that accompanies this book in order to add the capability to handle C-Codes. The metadata spreadsheets were updated accordingly. Any manager or user of clinical trial data in this day and age is likely to benefit from knowing how to either put data into a CDISC standard or analyzing and finding data once it is in a CDISC format. If you are one such person--a data manager, clinical and/or statistical programmer, biostatistician, or even a clinician--then this book is for you.
Elementary Statistics Using SAS by Sandra D. Schlotzhauer Pdf
Bridging the gap between statistics texts and SAS documentation, Elementary Statistics Using SAS is written for those who want to perform analyses to solve problems. The first section of the book explains the basics of SAS data sets and shows how to use SAS for descriptive statistics and graphs. The second section discusses fundamental statistical concepts, including normality and hypothesis testing. The remaining sections of the book show analyses for comparing two groups, comparing multiple groups, fitting regression equations, and exploring contingency tables. For each analysis, author Sandra Schlotzhauer explains assumptions, statistical approach, and SAS methods and syntax, and makes conclusions from the results. Statistical methods covered include two-sample t-tests, paired-difference t-tests, analysis of variance, multiple comparison techniques, regression, regression diagnostics, and chi-square tests. Elementary Statistics Using SAS is a thoroughly revised and updated edition of Ramon Littell and Sandra Schlotzhauer's SAS System for Elementary Statistical Analysis.
Elementary Statistics Using SAS by Sandra D. Schlotzhauer Pdf
Bridging the gap between statistics texts and SAS documentation, Elementary Statistics Using SAS is written for those who want to perform analyses to solve problems. The first section of the book explains the basics of SAS data sets and shows how to use SAS for descriptive statistics and graphs. The second section discusses fundamental statistical concepts, including normality and hypothesis testing. The remaining sections of the book show analyses for comparing two groups, comparing multiple groups, fitting regression equations, and exploring contingency tables. For each analysis, author Sandra Schlotzhauer explains assumptions, statistical approach, and SAS methods and syntax, and makes conclusions from the results. Statistical methods covered include two-sample t-tests, paired-difference t-tests, analysis of variance, multiple comparison techniques, regression, regression diagnostics, and chi-square tests. Elementary Statistics Using SAS is a thoroughly revised and updated edition of Ramon Littell and Sandra Schlotzhauer's SAS System for Elementary Statistical Analysis. This book is part of the SAS Press program.
Common Statistical Methods for Clinical Research with SAS Examples by Glenn A. Walker Pdf
This updated edition provides clinical researchers with an invaluable aid for understanding the statistical methods cited most frequently in clinical protocols, statistical analysis plans, clinical and statistical reports, and medical journals. The text is written in a way that takes the non-statistician through each test using examples, yet substantive details are presented that benefit even the most experienced data analysts.
Multiple Testing Problems in Pharmaceutical Statistics by Alex Dmitrienko,Ajit C. Tamhane,Frank Bretz Pdf
Useful Statistical Approaches for Addressing Multiplicity IssuesIncludes practical examples from recent trials Bringing together leading statisticians, scientists, and clinicians from the pharmaceutical industry, academia, and regulatory agencies, Multiple Testing Problems in Pharmaceutical Statistics explores the rapidly growing area of multiple c
A Handbook of Statistical Graphics Using SAS ODS by Geoff Der,Brian S. Everitt Pdf
Easily Use SAS to Produce Your Graphics Diagrams, plots, and other types of graphics are indispensable components in nearly all phases of statistical analysis, from the initial assessment of the data to the selection of appropriate statistical models to the diagnosis of the chosen models once they have been fitted to the data. Harnessing the full graphics capabilities of SAS, A Handbook of Statistical Graphics Using SAS ODS covers essential graphical methods needed in every statistician’s toolkit. It explains how to implement the methods using SAS 9.4. The handbook shows how to use SAS to create many types of statistical graphics for exploring data and diagnosing fitted models. It uses SAS’s newer ODS graphics throughout as this system offers a number of advantages, including ease of use, high quality of results, consistent appearance, and convenient semiautomatic graphs from the statistical procedures. Each chapter deals graphically with several sets of example data from a wide variety of areas, such as epidemiology, medicine, and psychology. These examples illustrate the use of graphic displays to give an overview of data, to suggest possible hypotheses for testing new data, and to interpret fitted statistical models. The SAS programs and data sets are available online.
Clinical Trial Data Analysis Using R and SAS by Ding-Geng (Din) Chen,Karl E. Peace,Pinggao Zhang Pdf
Review of the First Edition "The goal of this book, as stated by the authors, is to fill the knowledge gap that exists between developed statistical methods and the applications of these methods. Overall, this book achieves the goal successfully and does a nice job. I would highly recommend it ...The example-based approach is easy to follow and makes the book a very helpful desktop reference for many biostatistics methods."—Journal of Statistical Software Clinical Trial Data Analysis Using R and SAS, Second Edition provides a thorough presentation of biostatistical analyses of clinical trial data with step-by-step implementations using R and SAS. The book’s practical, detailed approach draws on the authors’ 30 years’ experience in biostatistical research and clinical development. The authors develop step-by-step analysis code using appropriate R packages and functions and SAS PROCS, which enables readers to gain an understanding of the analysis methods and R and SAS implementation so that they can use these two popular software packages to analyze their own clinical trial data. What’s New in the Second Edition Adds SAS programs along with the R programs for clinical trial data analysis. Updates all the statistical analysis with updated R packages. Includes correlated data analysis with multivariate analysis of variance. Applies R and SAS to clinical trial data from hypertension, duodenal ulcer, beta blockers, familial andenomatous polyposis, and breast cancer trials. Covers the biostatistical aspects of various clinical trials, including treatment comparisons, time-to-event endpoints, longitudinal clinical trials, and bioequivalence trials.
