Wei Zhao - Böcker

Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation strategies. Statistical Methods for Immunogenicity Assessment provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity.The book first gives an overview of the impact of immunogenicity on biopharmaceutical development, regulatory requirements, and statistical methods and strategies used for immunogenicity detection, quantification, and risk assessment and mitigation. It then covers anti-drug antibody (ADA) assay development, optimization, validation, and transfer as well as the analysis of cut point, a key assay performance parameter in ADA assay development and validation. The authors illustrate how to apply statistical modeling approaches to establish associations between ADA and clinical outcomes, predict immunogenicity risk, and develop risk mitigation strategies. They also present various strategies for immunogenicity risk control. The book concludes with an explanation of the computer codes and algorithms of the statistical methods.A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. It is an invaluable resource for anyone involved in immunogenicity risk assessment and control in both non-clinical and clinical biopharmaceutical development.

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. However, despite these advances, no book has served as a single source of information for statistical methods in drug combination research, nor has there been any guidance for experimental strategies.Statistical Methods in Drug Combination Studies fills that gap, covering all aspects of drug combination research, from designing in vitro drug combination studies to analyzing clinical trial data. Featuring contributions from researchers in industry, academia, and regulatory agencies, this comprehensive reference:Describes statistical models used to characterize dose–response patterns of monotherapies and evaluate the combination drug synergyOffers guidance for estimating interaction indices and constructing their associated confidence intervals to assess drug interactionIntroduces a practical and innovative Bayesian approach to Phase I cancer trials, including actual trial examples to illustrate useExamines strategies in the fixed-dose combination therapy clinical development via case studies stemming from regulatory reviewsEvaluates computational tools and software packages used to apply novel statistical methods in combination drug developmentStatistical Methods in Drug Combination Studies provides researchers with a solid understanding of the available statistical methods and computational tools and how to apply them in drug combination studies. The book is equally useful for statisticians to become better equipped to deal with drug combination study design and analysis in their practice.

Challenges in Design and Implementation of Middlewares for Real-Time Systems brings together in one place important contributions and up-to-date research results in this fast moving area. Challenges in Design and Implementation of Middlewares for Real-Time Systems serves as an excellent reference, providing insight into some of the most challenging research issues in the field.

Based on extended fieldwork conducted between 2007 and 2019, this book aims to answer a simple question: What is the meaning of home for people living in vernacular settlements in rural China? This question is particularly potent since rural China has experienced rapid and fundamental changes in the twenty-first century under the influences of national policies such as "Building a New Socialist Countryside" enacted in 2006 and "Rural Revitalization" announced in 2018. Drawing upon ethnographic fieldwork, building surveys, archival research, and over 600 photographs taken by residents along with their life stories, this book uncovers the meanings of home from rural residents’ perspectives, who belong to a social group that is underrepresented in scholarship and underserved in modern China. In other words, this study empowers rural residents by giving them voice. This book links the concepts of place, home, and tradition into an overarching argument: The meaning of home rests on the ideas of tradition, including identity, consanguinity, collectivity, social relations, land ownership, and rural lifestyle.The Introduction and Chapter 4 of this book is available for free in PDF format as Open Access from the individual product page at www.routledge.com. It has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 4.0 license.

Based on extended fieldwork conducted between 2007 and 2019, this book aims to answer a simple question: What is the meaning of home for people living in vernacular settlements in rural China? This question is particularly potent since rural China has experienced rapid and fundamental changes in the twenty-first century under the influences of national policies such as "Building a New Socialist Countryside" enacted in 2006 and "Rural Revitalization" announced in 2018. Drawing upon ethnographic fieldwork, building surveys, archival research, and over 600 photographs taken by residents along with their life stories, this book uncovers the meanings of home from rural residents’ perspectives, who belong to a social group that is underrepresented in scholarship and underserved in modern China. In other words, this study empowers rural residents by giving them voice. This book links the concepts of place, home, and tradition into an overarching argument: The meaning of home rests on the ideas of tradition, including identity, consanguinity, collectivity, social relations, land ownership, and rural lifestyle.The Introduction and Chapter 4 of this book is available for free in PDF format as Open Access from the individual product page at www.routledge.com. It has been made available under a Creative Commons Attribution-Non Commercial-No Derivatives 4.0 license.

Challenges in Design and Implementation of Middlewares for Real-Time Systems brings together in one place important contributions and up-to-date research results in this fast moving area. Challenges in Design and Implementation of Middlewares for Real-Time Systems serves as an excellent reference, providing insight into some of the most challenging research issues in the field.

This book introduces high power semiconductor laser packaging design. The challenges of the design and various packaging and testing techniques are detailed by the authors. New technologies and current applications are described in detail.

The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical methodologies. The theoretical development, coupled with advances in statistical computing, makes it possible to apply these emerging statistical methods in in vitro and in vivo drug combination assessments. However, despite these advances, no book has served as a single source of information for statistical methods in drug combination research, nor has there been any guidance for experimental strategies.Statistical Methods in Drug Combination Studies fills that gap, covering all aspects of drug combination research, from designing in vitro drug combination studies to analyzing clinical trial data. Featuring contributions from researchers in industry, academia, and regulatory agencies, this comprehensive reference:Describes statistical models used to characterize dose–response patterns of monotherapies and evaluate the combination drug synergyOffers guidance for estimating interaction indices and constructing their associated confidence intervals to assess drug interactionIntroduces a practical and innovative Bayesian approach to Phase I cancer trials, including actual trial examples to illustrate useExamines strategies in the fixed-dose combination therapy clinical development via case studies stemming from regulatory reviewsEvaluates computational tools and software packages used to apply novel statistical methods in combination drug developmentStatistical Methods in Drug Combination Studies provides researchers with a solid understanding of the available statistical methods and computational tools and how to apply them in drug combination studies. The book is equally useful for statisticians to become better equipped to deal with drug combination study design and analysis in their practice.

This book introduces high power semiconductor laser packaging design. The challenges of the design and various packaging and testing techniques are detailed by the authors. New technologies and current applications are described in detail.

Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation strategies. Statistical Methods for Immunogenicity Assessment provides a single source of information on statistical concepts, principles, methods, and strategies for detection, quantification, assessment, and control of immunogenicity.The book first gives an overview of the impact of immunogenicity on biopharmaceutical development, regulatory requirements, and statistical methods and strategies used for immunogenicity detection, quantification, and risk assessment and mitigation. It then covers anti-drug antibody (ADA) assay development, optimization, validation, and transfer as well as the analysis of cut point, a key assay performance parameter in ADA assay development and validation. The authors illustrate how to apply statistical modeling approaches to establish associations between ADA and clinical outcomes, predict immunogenicity risk, and develop risk mitigation strategies. They also present various strategies for immunogenicity risk control. The book concludes with an explanation of the computer codes and algorithms of the statistical methods.A critical issue in the development of biologics, immunogenicity can cause early termination or limited use of the products if not managed well. This book shows how to use robust statistical methods for detecting, quantifying, assessing, and mitigating immunogenicity risk. It is an invaluable resource for anyone involved in immunogenicity risk assessment and control in both non-clinical and clinical biopharmaceutical development.

This book systematically introduces magnetic flux leakage testing principles and their applications in practice. Signal detection, collection, processing, the inversion of magnetic flux leakage defect and 3D imaging are discussed in detail with extensive project experiences, making the book an essential reference for researchers, developers and engineers in nondestructive testing.

Welcome to Zhangjiajie for the 3rd International Conference on Computer Network and Mobile Computing (ICCNMC 2005).

Welcome to the proceedings of the 2005 International Conference on Emb- ded Software and Systems (ICESS 2005) held in Xian, China, December 16-18, 2005. With the advent of VLSI system level integration and system-on-chip, the center of gravity of the computer industry is now moving from personal c- puting into embedded computing. Embedded software and systems are incre- ingly becoming a key technological component of all kinds of complex technical systems, ranging from vehicles, telephones, aircraft, toys, security systems, to medical diagnostics, weapons, pacemakers, climate control systems, etc. The ICESS 2005 conference provided a premier international forum for - searchers, developers and providers from academia and industry to address all resulting profound challenges; to present and discuss their new ideas, - search results, applications and experience; to improve international com- nication and cooperation; and to promote embedded software and system - dustrialization and wide applications on all aspects of embedded software and systems.

This book offers a systematic investigation of the ecological and environmental issues related to the land cover changes in Nepal by researchers from both China and Nepal. It discusses the eco-environmental issues faced by Nepal, particularly in the hills and mountain regions. It also sheds light on the global concerns regarding the eco-environment issues of mountains, and analyzes the various causes and potential consequences of eco-environmental degradation in Nepal. The book is of particular interest to students, researchers, experts, and decision-makers wanting to gain a general overview of land cover in Nepal and its dynamics, environment and natural resources, as well as mountain hazards.

This book offers a systematic investigation of the ecological and environmental issues related to the land cover changes in Nepal by researchers from both China and Nepal. It discusses the eco-environmental issues faced by Nepal, particularly in the hills and mountain regions. It also sheds light on the global concerns regarding the eco-environment issues of mountains, and analyzes the various causes and potential consequences of eco-environmental degradation in Nepal. The book is of particular interest to students, researchers, experts, and decision-makers wanting to gain a general overview of land cover in Nepal and its dynamics, environment and natural resources, as well as mountain hazards.

This book constitutes the proceedings of the 9th CCF Conference on Big Data, BigData 2021, held in Guangzhou, China, in January 2022. They present recent research on theoretical and technical aspects on big data, as well as on digital economy demands in big data applications.

The main objectives of the book are to introduce the design method of boundary control strategies for the axially moving structures to reduce their vibration. Our goal is to provide advanced boundary controller design methods and their stability analysis methods and offer simulation examples and MATLAB programs for each boundary control algorithm.

The main objectives of the book are to introduce the design method of boundary control strategies for the axially moving structures to reduce their vibration. Our goal is to provide advanced boundary controller design methods and their stability analysis methods and offer simulation examples and MATLAB programs for each boundary control algorithm.

Since the reform and opening-up in the late 1970s, Wenzhou City of China's Zhejiang Province has witnessed large-scale institutional change and rapid economic development. This book studies the institutional change and economic development in Wenzhou since China's reform and opening-up. It concludes that the most important characteristic of Wenzhou model is that the city is the first to promote industrialization and urbanization by privatization and marketization in Zhejiang. As privatization and marketization reflect reform, and industrialization and urbanization represent development, Wenzhou model promotes development through economic reform. In the early years of the reform and opening-up, the people of Wenzhou boldly faced the constraints of traditional planned economy, bravely explored the market-oriented reform and opened up a new path to regional economic development. This book also contains the stories of the people of Wenzhou.