Statistical Methods for Immunogenicity Assessment (Chapman & Hall/CRC Biostatistics Series)

Develop Effective Immunogenicity Risk Mitigation Strategies\nImmunogenicity 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.\nThe 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.\nA 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.

Science & Math

Yang, Harry

Zhang, Jianchun

Yu, Binbing

Zhao, Wei

Biological Sciences

Routledge

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.

Home Beyond the House (Explorations in Housing Studies)

Reference

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.

Packaging of High Power Semiconductor Lasers (Micro- and Opto-Electronic Materials, Structures, and Systems)

Liu, Hui

Liu, Xingsheng

Xiong, Lingling

Physics

Springer

Develop Effective Immunogenicity Risk Mitigation Strategies Immunogenicity 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.

Chapman and Hall/CRC

First position Zhiwei practice - Vicki violin tutorial -1 - ( attached DVD1 sheets )

People's Music

Steel Bridge(Chinese Edition)

China Communications Press

Dictionary of anti-cancer diet(Chinese Edition)

China Textile Press

Paperback. Pub Date :2014-06-01 Publisher: Jiangsu Literature and Art Publishing House is by far probably the most straightforward. most practical for large data books! Because. in addition to the book. no other book makes you so close to the big data era of China and the future is now! Big Data in China. using the most streamlined text. the most detailed analysis of the characteristics of big data case. the principle and the use of various areas of China in the moment. While giving businesses and individuals to provide us a new reference - the era of big data will provide what support Chinese enterprises in transition? Our strengths and weaknesses and where? How big data thinking into use in management. marketing. and all aspects of life among the? And how to catch our personal big data. the Express business value and personal ideals? The book not only shows Microsoft. Amaz...

Big Data in China(Chinese Edition)

Jiangsu Literature and Art Publishing House

Dynamic Modeling and Boundary Control of Flexible Axially Moving System

Engineering & Transportation

刘瑜

Liu, Fengjiao

Mei, Yanfang

Yao, Xiangqian

Engineering

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