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Informationen zum Autor Editors FREDERICK W. FALTIN, Founder and Managing Director, The Faltin Group, Cody, WY, USA. RON S. KENETT, Chairman and CEO, The KPA Group, Raanana, Israel. FABRIZIO RUGGERI, Research Director, CNR IMATI, Milan, Italy. Klappentext In recent years the number of innovative medicinal products and devices submitted and approved by regulatory bodies has declined dramatically. The medical product development process is no longer able to keep pace with increasing technologies, science and innovations and the goal is to develop new scientific and technical tools and to make product development processes more efficient and effective. Statistical Methods in Healthcare focuses on the application of statistical methodologies to evaluate promising alternatives and to optimize the performance and demonstrate the effectiveness of those that warrant pursuit is critical to success. Statistical methods used in planning, delivering and monitoring health care, as well as selected statistical aspects of the development and/or production of pharmaceuticals and medical devices are also addressed.With a focus on finding solutions to these challenges, this book:* Provides a comprehensive, in-depth treatment of statistical methods in healthcare, along with a reference source for practitioners and specialists in health care and drug development.* Offers a broad coverage of standards and established methods through leading edge techniques.* Uses an integrated, case-study based approach, with focus on applications.* Looks at the use of analytical and monitoring schemes to evaluate therapeutic performance.* Features the application of modern quality management systems to clinical practice, and to pharmaceutical development and production processes.* Addresses the use of modern Statistical methods such as Adaptive Design, Seamless Design, Data Mining, Bayesian networks and Bootstrapping that can be applied to support the challenging new vision.Practitioners in healthcare-related professions, ranging from clinical trials to care delivery to medical device design, as well as statistical researchers in the field, will benefit from this book. Zusammenfassung * Provides a comprehensive, in-depth treatment of statistical methods in healthcare. * Presents a reference source for practitioners and specialists in health care and drug development. * Offers a broad coverage of standards and established methods through leading edge techniques. Inhaltsverzeichnis Foreword xix Preface xxi Editors xxiii Contributors xxv Part One STATISTICS IN THE DEVELOPMENT OF PHARMACEUTICAL PRODUCTS 1 Statistical Aspects in ICH, FDA and EMA Guidelines 3 Allan Sampson and Ron S. Kenett 2 Statistical Methods in Clinical Trials 22 Telba Irony, Caiyan Li and Phyllis Silverman 3 Pharmacometrics in Drug Development 56 Serge Guzy and Robert Bauer 4 Interactive Clinical Trial Design 78 Zvia Agur 5 Stage-wise Clinical Trial Experiments in Phases I, II and III 103 Shelemyahu Zacks 6 Risk Management in Drug Manufacturing and Healthcare 122 Ron S. Kenett 7 The Twenty-first Century Challenges in Drug Development 155 Yafit Stark Part Two STATISTICS IN OUTCOMES ANALYSIS 8 The Issue of Bias in Combined Modelling and Monitoring of Health Outcomes 169 Olivia A. J. Grigg 9 Disease Mapping 185 Annibale Biggeri and Dolores Catelan 10 Process Indicators and Outcome Measures in the Treatment of Acute Myocardial Infarction Patients 219 Alessandra Guglielmi, Francesca Ieva, Anna Maria Paganoni and Fabrizio Ruggeri 11 Meta-analysis 230 Eva Negri Part Three STATISTICAL PROCESS CONTROL IN HEALTHCARE ...
