"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

Preeminent Experts Update a Well-Respected Book Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology. New to the Third Edition Four new chapters that present a thorough account of novel developments in the field New and updated sections that reflect recent advances in the statistical methodology in the design and analysis of bioavailability and bioequivalence studies Reorganization of the material into five parts, making it easier to access related information together Over 100 new references from the literature Like its bestselling predecessors, this edition covers all of the statistical problems that may occur in the various stages of design and data analysis. Keeping the mathematics and statistics at a fundamental level, it continues to focus on practical concepts rather than technical details.

"Offers a comprehensive, unified presentation of statistical designs and methods of analysis for all stages of pharmaceutical development--emphasizing biopharmaceutical applications and demonstrating statistical techniques with real-world examples."

As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region. Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.

"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "

As the development of medicines has become more globalized, the geographic variations in the efficacy and safety of pharmaceutical products need to be addressed. To accelerate the product development process and shorten approval time, researchers are beginning to design multiregional trials that incorporate subjects from many countries around the world under the same protocol. Design and Analysis of Bridging Studies addresses the issues arising from bridging studies and multiregional clinical trials. For bridging studies, the book explores ethnic sensitivity, the necessity of bridging studies, types of bridging studies, and the assessment of similarity between regions based on bridging evidence. For multiregional clinical trials, the text considers regional differences, assesses the consistency of treatment effect across regions, and discusses sample size determination for each region. Taking into account the International Conference Harmonisation (ICH) E5 framework for bridging studies, the book provides a unified summary of the growing literature and research activities in this area. It covers the regulatory requirements, scientific and practical issues, and statistical methodology for designing and evaluating bridging studies and multiregional clinical trials, with the goal of inspiring new research activities in the field.

Taking into account the regulatory and scientific developments that have occurred since the second edition, Design and Analysis of Bioavailability and Bioequivalence Studies, Third Edition provides a complete presentation of the latest progress of activities and results in bioavailability and bioequivalence on regulatory requirements, scientific and practical issues, and statistical methodology.

New to the Third Edition

- Four new chapters that present a thorough account of novel developments in the field

- New and updated sections that reflect recent advances in the statistical methodology in the design and analysis of bioavailability and bioequivalence studies

- Reorganization of the material into five parts, making it easier to access related information together

- Over 100 new references from the literature

Like its bestselling predecessors, this edition covers all of the statistical problems that may occur in the various stages of design and data analysis. Keeping the mathematics and statistics at a fundamental level, it continues to focus on practical concepts rather than technical details.

This book provides a scientific framework for integrated solutions to complex energy problems. It adopts a holistic, systems-based approach to demonstrate the potential of an energy systems engineering approach to systematically quantify different options at various levels of complexity (technology, plant, energy supply chain, mega-system). Utilizing modeling, simulation and optimization-based frameworks, along with a number of real-life applications, it focuses on advanced energy systems including energy supply chains, integrated biorefineries, energy planning and scheduling approaches and urban energy systems. Featuring contributions from leading researchers in the field, this work is useful for academics, researchers, industry practitioners in energy systems engineering, and all those who are involved in model-based energy systems.

This book describes the scale and complexity of China's energy system, using Sankey diagrams to visualize the energy flows across the economy and categorizing the differences between provinces. China's provinces extend over a vast area and are at different stages of economic development. Regional planning and inter-regional optimization will be essential for planning a future infrastructure that will allow China as a whole to optimize and avoid overcapacity and inefficiency. In this context, it introduces a new energy systems modeling approach and demonstrates its application in the power sector. This power model can help optimize the overall design of the power system and reveal how different future investment choices, e.g. natural gas fired power, only emerge when details such as regional, seasonal and diurnal demand factors are considered. Lastly, it looks at options for mitigating carbon and the major role that renewables & natural gas could play, as well as carbon pricing.

This book provides a scientific framework for integrated solutions to complex energy problems. It adopts a holistic, systems-based approach to demonstrate the potential of an energy systems engineering approach to systematically quantify different options at various levels of complexity (technology, plant, energy supply chain, mega-system). Utilizing modeling, simulation and optimization-based frameworks, along with a number of real-life applications, it focuses on advanced energy systems including energy supply chains, integrated biorefineries, energy planning and scheduling approaches and urban energy systems. Featuring contributions from leading researchers in the field, this work is useful for academics, researchers, industry practitioners in energy systems engineering, and all those who are involved in model-based energy systems.

This book describes the scale and complexity of China's energy system, using Sankey diagrams to visualize the energy flows across the economy and categorizing the differences between provinces. China's provinces extend over a vast area and are at different stages of economic development. Regional planning and inter-regional optimization will be essential for planning a future infrastructure that will allow China as a whole to optimize and avoid overcapacity and inefficiency. In this context, it introduces a new energy systems modeling approach and demonstrates its application in the power sector. This power model can help optimize the overall design of the power system and reveal how different future investment choices, e.g. natural gas fired power, only emerge when details such as regional, seasonal and diurnal demand factors are considered. Lastly, it looks at options for mitigating carbon and the major role that renewables & natural gas could play, as well as carbon pricing.

This book constitutes the thoroughly refereed post-conference proceedings of the 6th International ICST Conference on Wireless Internet (WICON 2011) held in Xi'an, Shaanxi, China in October 2011. The 55 revised full papers were carefully selected from numerous submissions and focus on research in telecommunication and networking and development in information and communication technologies. The papers are presented in 10 technical sessions and cover topics as video streaming over OFDMA downlink systems, cognitive radio networks, distributed antenna systems, joint source channel coding, multiuser MIMO systems, signal detection, frequency synchronization in 3GPP LTE systems, visual cognitive radio, wireless relay networks, and network flow identifying methods.

Problems facing manufacturing clusters that intersect information technology, process management, and optimization within the Internet of Things (IoT) are examined in this book. Recent advances in information technology have transformed the use of resources and data exchange, often leading to management and optimization problems attributatble to technology limitations and strong market competition. This book discusses several problems and concepts which makes significant connections in the areas of information sharing, organization management, resource operations, and performance assessment. Geared toward practitioners and researchers, this treatment deepens the understanding between resource collaborative management and advanced information technology. Those in manufacturing will utilize the numerous mathematical models and methods offered to solve practical problems related to cutting stock, supply chain scheduling, and inventory management. Academics and students with a basic knowledge of manufacturing, combinatorics, and linear programming will find that this discussion widens the research area of resource collaborative management and unites the fields of information technology, manufacturing management, and optimization.