Автор: Weili He; Jos? Pinheiro; Olga M. Kuznetsova Название: Practical Considerations for Adaptive Trial Design and Implementation ISBN: 149391099X ISBN-13(EAN): 9781493910991 Издательство: Springer Рейтинг: Цена: 158380.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
Автор: Cheng Wang Название: Hot Carrier Design Considerations for MOS Devices and Circuits ISBN: 1468485490 ISBN-13(EAN): 9781468485493 Издательство: Springer Рейтинг: Цена: 93160.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book ad- dresses these hot-carrier design issues for MOS devices and circuits, and is used primarily as a professional guide for process development engi- neers, device engineers, and circuit designers who are interested in the latest developments in hot-carrier degradation modeling and hot-carrier reliability design techniques.
Автор: Weili He; Jos? Pinheiro; Olga M. Kuznetsova Название: Practical Considerations for Adaptive Trial Design and Implementation ISBN: 149395539X ISBN-13(EAN): 9781493955398 Издательство: Springer Рейтинг: Цена: 158380.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, in particular, statisticians, clinicians, pharmacometricians, clinical operation specialists, drug supply managers, and infrastructure providers. In spite of the increased efficiency of adaptive trials in saving costs and time, ultimately getting drugs to patients sooner, their adoption in clinical development is still relatively low. One of the chief reasons is the higher complexity of adaptive design trials as compared to traditional trials. Barriers to the use of clinical trials with adaptive features include the concerns about the integrity of study design and conduct, the risk of regulatory non-acceptance, the need for an advanced infrastructure for complex randomization and clinical supply scenarios, change management for process and behavior modifications, extensive resource requirements for the planning and design of adaptive trials and the potential to relegate key decision makings to outside entities. There have been limited publications that address these practical considerations and recommend best practices and solutions. This book fills this publication gap, providing guidance on practical considerations for adaptive trial design and implementation. The book comprises three parts: Part I focuses on practical considerations from a design perspective, whereas Part II delineates practical considerations related to the implementation of adaptive trials. Putting it all together, Part III presents four illustrative case studies ranging from description and discussion of specific adaptive trial design considerations to the logistic and regulatory issues faced in trial implementation. Bringing together the expertise of leading key opinion leaders from pharmaceutical industry, academia, and regulatory agencies, this book provides a balanced and comprehensive coverage of practical considerations for adaptive trial design and implementation.
Автор: J. Virant Название: Design Considerations of Time in Fuzzy Systems ISBN: 0792361008 ISBN-13(EAN): 9780792361008 Издательство: Springer Рейтинг: Цена: 204040.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Observes the role of time in fuzzy proposition calculations, provides calculation error analysis for small density of inference processing and gives numerous examples of fuzzy sets and systems programming with time incorporated into a fuzzy inference machine based on MATLAB and Mathematica packages.
Автор: J. Virant Название: Design Considerations of Time in Fuzzy Systems ISBN: 1461371155 ISBN-13(EAN): 9781461371151 Издательство: Springer Рейтинг: Цена: 186330.00 T Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: DiBerardinis Название: Guidelines for Laboratory Design: Health, Safety, and Environmental Considerations, 4th Edition ISBN: 0470505524 ISBN-13(EAN): 9780470505526 Издательство: Wiley Рейтинг: Цена: 140390.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: The new edition of this book addresses the many changes in laboratory design since the previous edition was published in 2001. It focuses on advances in environmental design and green laboratories while bringing up to date all health and safety aspects of lab design.
Автор: Scrope Название: Considerations on Volcanos ISBN: 1108072305 ISBN-13(EAN): 9781108072304 Издательство: Cambridge Academ Рейтинг: Цена: 32730.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: George Scrope`s Considerations on Volcanos (1825) contains the results of his observations in the volcanic regions of France, Italy and Germany. It was one of the first attempts at a comprehensive theory of volcanic action and an understanding of the significance of volcanos as evidence for the earth`s geological history.
Автор: Ferrari Название: Antisense-Based Drugs and Therapeutics: Preclinica l and Clinical Considerations for Development ISBN: 1118537335 ISBN-13(EAN): 9781118537336 Издательство: Wiley Рейтинг: Цена: 188970.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Antisense-based drugs are part of a growing number of pharmaceutical and biotech programs to treat diseases including cancer, diabetes, and ALS. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide from the safety assessment to clinical experience with antisense oligonucleotides.
Автор: Kerry B. Barker, Sandeep M. Menon, Ralph B. D`Agostino, Siyan Xu, Bo Jin Название: Biosimilar Clinical Development: Scientific Considerations and New Methodologies ISBN: 1482231697 ISBN-13(EAN): 9781482231694 Издательство: Taylor&Francis Рейтинг: Цена: 132710.00 T Наличие на складе: Нет в наличии. Описание: Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already impacting both clinical research and patient care, and this impact will only grow as our understanding and technologies improve. Written by a team of experienced specialists in clinical development, this book discusses various potential drug development strategies, the design and analysis of pharmacokinetics (PK) studies, and the design and analysis of efficacy studies.
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