Statistics In the Pharmaceutical Industry, Bosch, Ronald J.
Автор: Krickeberg Klaus, Van Trong Pham, Thi My Hanh Pham Название: Epidemiology: Key to Public Health. 2 ed. ISBN: 3030163679 ISBN-13(EAN): 9783030163679 Издательство: Springer Рейтинг: Цена: 93160.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: ?This unique textbook presents the field of modern epidemiology as a whole; it does not restrict itself to particular aspects. It stresses the fundamental ideas and their role in any situation of epidemiologic practice. Its structure is largely determined by didactic viewpoints.Epidemiology is the art of defining and investigating the influence of factors on the health of populations. Hence the book starts by sketching the role of epidemiology in public health. It then treats the epidemiology of many particular diseases; mathematical modelling of epidemics and immunity; health information systems; statistical methods and sample surveys; clinical epidemiology including clinical trials; nutritional, environmental, social, and genetic epidemiology; and the habitual tools of epidemiologic studies. The book also reexamines the basic difference between the epidemiology of infectious diseases and that of non-infectious ones.The organization of the topics by didactic aspects makes the book ideal for teaching. All examples and case studies are situated in a single country, namely Vietnam; this provides a particularly vivid picture of the role of epidemiology in shaping the health of a population. It can easily be adapted to other developing or transitioning countries.This volume is well suited for courses on epidemiology and public health at the upper undergraduate and graduate levels, while its specific examples make it appropriate for those who teach these fields in developing or emerging countries. New to this edition, in addition to minor revisions of almost all chapters:• Updated data about infectious and non-infectious diseases• An expanded discussion of genetic epidemiology• A new chapter, based on recent research of the authors, on how to build a coherent system of Public Health by using the insights provided by this volume.
Автор: Trevor Hastie; Robert Tibshirani; Jerome Friedman Название: The Elements of Statistical Learning ISBN: 0387848576 ISBN-13(EAN): 9780387848570 Издательство: Springer Рейтинг: Цена: 69870.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This major new edition features many topics not covered in the original, including graphical models, random forests, and ensemble methods. As before, it covers the conceptual framework for statistical data in our rapidly expanding computerized world.
Автор: Watson, David G. (Senior Lecturer in Pharmaceutical Sciences, Strathclyde Institute of Pharmaceutical and Biomedical Sciences, University of Strathcly Название: Pharmaceutical and Medicinal Chemistry. Elsevier,2011 ISBN: 9780443072321\Давид Уотсон:Фармацевтическая и лекарственная химия, Элзивир,2011 ISBN: 0443072329 ISBN-13(EAN): 9780443072321 Издательство: Elsevier Science Рейтинг: Цена: 49390.00 T Наличие на складе: Поставка под заказ. Описание: Intends to define the area of pharmaceutical chemistry as distinct from medicinal chemistry. This book emphasizes on the physicochemical properties of drug molecules and, in so far as they are known, the way that these properties govern the interaction of the drug with its target.
Автор: Burdick Название: Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry ISBN: 3319501844 ISBN-13(EAN): 9783319501840 Издательство: Springer Рейтинг: Цена: 79190.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities.
Автор: Millard Steven P., Krause Andreas Название: Applied Statistics in the Pharmaceutical Industry / With Case Studies Using S-PLUS ISBN: 0387988149 ISBN-13(EAN): 9780387988146 Издательство: Springer Рейтинг: Цена: 144410.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Each year hundreds of new drugs are approved for the marketplace. The approval of a single new drug is the result of years of screening tens of thousands of compounds, performing pre-clinical research on their effects, and designing, implementing, and analyzing the results of clinical trials. This book provides a general guide to statistical methods used in the pharmaceutical industry, and is aimed at graduate students and researchers who want to know more about statistical applications in all phases of the drug development process. The 19 chapters authored by over 30 statisticians working in the industry follow the general sequence of drug development, from pre-clinical research and saftey assessment to dose finding, safety studies, large clinical trials, analysis of health economic data, and fianlly manufacturing and production. Special topics such as single patient analysis and the impact of patient compliance show the broad spectrum of applications of data analysis methods. Each chapter illustrates a practical problem using data from actual studies by describing the study, the data, the methods, and the results. All of the analyses are done with S-PLUS, and the data and code are provided both in appendices to the chapters and on the companion Springer-Verlag web site, making it possible to reproduce the results and extend the analyses. Prior knowledge of the software is not required to follow the analyses. Steven P. Millard is a statistical consultant and also Manager of Consulting Services for MathSoft, Inc. (Data Analysis Products Division.) He has applied statistical methods to projects ranging from quality control in bioassay to measuring water quality to automating home appraisal, and has taught courses in S-PLUS for over 10 years. He is the author of the book Environmental Statistics with S-PLUS (CRC Press) as well as the S-PLUS add-in module ENVIRONMENTALSTATS for S-PLUS. Andreas Krause is a statistical consultant in the pharmaceutical industry and works for Novartis Pharma AG. He has extensive experience in graphical and numerical data analysis as well as programming, has taught numerous classes with and on S-PLUS, and is an S_PLUS user from the early days on. He is also author of the book The Basics of S and S-PLUS (Springer).
Автор: Fairclough Название: Design and Analysis of Quality of Life Studies in Clinical Trials, Second Edition ISBN: 1420061178 ISBN-13(EAN): 9781420061178 Издательство: Taylor&Francis Рейтинг: Цена: 148010.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Presents a range of solutions to analytic issues. This title reflects developments in methodology with coverage of mixture models and a dataset example. It implements examples using SAS and R code and incorporates a number of examples from real QoL clinical trials to illustrate design and analysis methods.
Название: Clinical Trial Optimization using R ISBN: 149873507X ISBN-13(EAN): 9781498735070 Издательство: Taylor&Francis Рейтинг: Цена: 107190.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
Clinical Trial Optimization Using R explores a unified and broadly applicable framework for optimizing decision making and strategy selection in clinical development, through a series of examples and case studies. It provides the clinical researcher with a powerful evaluation paradigm, as well as supportive R tools, to evaluate and select among simultaneous competing designs or analysis options. It is applicable broadly to statisticians and other quantitative clinical trialists, who have an interest in optimizing clinical trials, clinical trial programs, or associated analytics and decision making.
This book presents in depth the Clinical Scenario Evaluation (CSE) framework, and discusses optimization strategies, including the quantitative assessment of tradeoffs. A variety of common development challenges are evaluated as case studies, and used to show how this framework both simplifies and optimizes strategy selection. Specific settings include optimizing adaptive designs, multiplicity and subgroup analysis strategies, and overall development decision-making criteria around Go/No-Go. After this book, the reader will be equipped to extend the CSE framework to their particular development challenges as well.
Автор: de Muth James E. Название: Practical Statistics for Pharmaceutical Analysis: With Minitab Applications ISBN: 3030339912 ISBN-13(EAN): 9783030339913 Издательство: Springer Цена: 79190.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This is an introductory statistics book designed to provide scientists with practical information needed to apply the most common statistical tests to laboratory research data.
Автор: Steven P. Millard; Andreas Krause Название: Applied Statistics in the Pharmaceutical Industry ISBN: 144193166X ISBN-13(EAN): 9781441931665 Издательство: Springer Рейтинг: Цена: 144410.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: 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.
Автор: Pfeiffer Название: A Practical Guide To Managing Clini ISBN: 1138196509 ISBN-13(EAN): 9781138196506 Издательство: Taylor&Francis Рейтинг: Цена: 96970.00 T Наличие на складе: Нет в наличии. Описание:
A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed for individuals working in research site operations, this user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.
Unique to this book is "A View from India," a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Автор: Karl E. Peace; Ding-Geng Chen; Sandeep Menon Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811340064 ISBN-13(EAN): 9789811340062 Издательство: Springer Рейтинг: Цена: 88500.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание:
This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.
The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications.
This book is the third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.
Автор: Wassmer Gernot, Brannath Werner Название: Group Sequential and Confirmatory Adaptive Designs in Clinical Trials ISBN: 3319813145 ISBN-13(EAN): 9783319813141 Издательство: Springer Рейтинг: Цена: 130430.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book provides an up-to-date review of the general principles of and techniques for confirmatory adaptive designs. Confirmatory adaptive designs are a generalization of group sequential designs. With these designs, interim analyses are performed in order to stop the trial prematurely under control of the Type I error rate. In adaptive designs, it is also permissible to perform a data-driven change of relevant aspects of the study design at interim stages. This includes, for example, a sample-size reassessment, a treatment-arm selection or a selection of a pre-specified sub-population. Essentially, this adaptive methodology was introduced in the 1990s. Since then, it has become popular and the object of intense discussion and still represents a rapidly growing field of statistical research. This book describes adaptive design methodology at an elementary level, while also considering designing and planning issues as well as methods for analyzing an adaptively planned trial. This includes estimation methods and methods for the determination of an overall p-value. Part I of the book provides the group sequential methods that are necessary for understanding and applying the adaptive design methodology supplied in Parts II and III of the book. The book contains many examples that illustrate use of the methods for practical application. The book is primarily written for applied statisticians from academia and industry who are interested in confirmatory adaptive designs. It is assumed that readers are familiar with the basic principles of descriptive statistics, parameter estimation and statistical testing. This book will also be suitable for an advanced statistical course for applied statisticians or clinicians with a sound statistical background.
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