Yihong Yao's Books

Genomic Biomarkers for Pharmaceutical Development

Chapter 7. Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration

By: Philip Brohawn,Brandon W. Higgs,Koustubh Ranade,Bahija Jallal,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 7. Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration

By: Philip Brohawn,Brandon W. Higgs,Koustubh Ranade,Bahija Jallal,Yihong Yao

This chapter presents the processes required for the translation of a biomarker discovery from the research laboratory into a validated diagnostic for clinical application. To fully investigate the topic of assay validation, a brief review of the current regulatory guidance will be discussed, and thereafter this is used as the framework for topics surrounding assay validation. The time-sensitive stages in the assay development process and agreement with clinical development timelines are critical to delivering a viable clinic-ready assay. Methods to best maneuver this are presented to help emphasize the necessary level of validation for use of an assay in a clinical setting. Each pertinent stage is then described, and key focus areas are highlighted. For certain stages of the development process, such as cut-point determination, multiple vs. single analyte, classifier training/testing, and precision determination, various statistical arguments are presented to illustrate common misconceptions or potential pitfalls.

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Elsevier Inc. Chapters

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ISBN 10

0128063564

ISBN 13

9780128063569

Genomic Biomarkers for Pharmaceutical Development

Chapter 3. Personalized Healthcare in Autoimmune Diseases

By: Cornelis L. Verweij,Brandon W. Higgs,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 3. Personalized Healthcare in Autoimmune Diseases

By: Cornelis L. Verweij,Brandon W. Higgs,Yihong Yao

Autoimmune diseases constitute a wide range of mostly complex and multifactorial disorders that are difficult to treat. Increasing insight in the pathogenesis of autoimmune diseases has led to development of targeted therapies aimed at regulating key components of the disease pathways. In particular, the advent of biologic therapeutics has led to significant advances in the treatment of autoimmune diseases. However, the multifactorial nature of the different clinical entities, reflected by the uniqueness of an individual’s genetic make-up and environmental factors, create a high degree of molecular and clinical heterogeneity within a clinically defined disease. Consequently, targeted therapies are not efficacious for all patients diagnosed with such a disease, and selection of therapies is still conducted on a trial-and-error basis. With the rapid advances in modern genomics and genetics technology, there has been some encouraging progress made in the last several years in developing genomic biomarkers as pharmacodynamics markers to evaluate target neutralization for dose selection in pivotal trials, and to identify and evaluate potential predictive markers for efficacy in targeted therapies. This chapter provides highlights and case studies in this field.

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Elsevier Inc. Chapters

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ISBN 10

0128063521

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9780128063521

Genomic Biomarkers for Pharmaceutical Development

Chapter 1. Application of Translational Science to Clinical Development

By: Koustubh Ranade,Brandon W. Higgs,Ruth March,Lorin Roskos,Bahija Jallal,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 1. Application of Translational Science to Clinical Development

By: Koustubh Ranade,Brandon W. Higgs,Ruth March,Lorin Roskos,Bahija Jallal,Yihong Yao

Despite the large and ever-growing investment in pharmaceutical R&D, the number of innovative new medicines that meet significant unmet medical needs has been stagnant, if not declining. There are many potential reasons for this low return on pharmaceutical R&D investment, but one likely cause is the low probability of the success of clinical trials, particularly in early clinical development. Translational science, which we define as identifying the ‘right’ patient for the ‘right’ drug at the ‘right’ dose, promises to improve not only the odds of success of clinical development, but perhaps more importantly, to get the right drug to the right patient, thereby sparing those patients who may be less likely to benefit from a new therapeutic. We believe that this goal can be achieved by putting the patient first, i.e., by investing in understanding of disease heterogeneity at the molecular level, and then tailoring new therapeutics to subsets of patients. Using examples from the literature and our own experience, we describe current and emerging translational approaches that employ genomic and genetic methods in the areas of cancer, inflammation, and metabolic and infectious disease to this end. We use simple simulations to demonstrate how such translational strategies can significantly reduce the size of clinical trials or increase the likelihood of success of early phase trials. We end by discussing genomic approaches to understand adverse drug reactions.

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Elsevier Inc. Chapters

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ISBN 10

0128063505

ISBN 13

9780128063507

Evidence-based Clinical Chinese Medicine - Volume 17: Colorectal Cancer

By: Brian H May,Yihong Liu

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Evidence-based Clinical Chinese Medicine - Volume 17: Colorectal Cancer

By: Brian H May,Yihong Liu

This seventeenth volume of the Evidence-based Clinical Chinese Medicine series aims to provide a multi-faceted 'whole evidence' analysis of the management of Colorectal Cancer in integrative Chinese medicine.Beginning with overviews of how colorectal cancer is conceptualised and managed in both conventional medicine and contemporary Chinese medicine, the authors then provide detailed analyses of how colorectal cancer and related disorders were treated with herbal medicine and acupuncture in past eras.In the subsequent chapters, the authors comprehensively review the current state of the clinical trial evidence for Chinese herbal medicines (Chapter 5), acupuncture (Chapter 7), other Chinese medicine therapies (Chapter 8) and combination Chinese medicine therapies (Chapter 9) in the management of colorectal cancer, as well as analyse and evaluate the results of these studies from an evidence-based medicine perspective. Chapter 6 provides a review and a summary of the experimental evidence for the bioactivity of commonly used Chinese herbs. The outcomes of these analyses are summarised and discussed in Chapter 10 which identifies implications for the clinical practice of Chinese medicine and for future research.This book can inform clinicians and students in the fields of integrative medicine and Chinese medicine regarding contemporary practice and the current evidence-base for a range of Chinese medicine therapies used in the management of colorectal cancer, including herbal formulas and acupuncture treatments, in order to assist clinicians in making evidence-based decisions in patient care.The following features mark the importance of this book in the field:

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532

Publisher

World Scientific

Published Date

ISBN 10

9811214204

ISBN 13

9789811214202

Evidence-based Clinical Chinese Medicine - Volume 18: Cancer Pain

By: Brian H May,Yihong Liu

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Evidence-based Clinical Chinese Medicine - Volume 18: Cancer Pain

By: Brian H May,Yihong Liu

This eighteenth volume of the Evidence-based Clinical Chinese Medicine series aims to provide a multi-faceted 'whole evidence' analysis of the management of pain due to a range of cancers (cancer pain) using integrative Chinese medicine.Beginning with an overview of how cancer pain is conceptualised and managed in conventional medicine, the authors then summarise the differential diagnosis and managment of cancer pain in contemporary Chinese medicine based on clinical guidelines and contemporary books. The third chapter provides detailed analyses of how cancer pain and related disorders were treated with herbal medicine and acupuncture in past eras based on the classical Chinese medical literature.The subsequent chapters comprehensively review the current state of the clinical trial evidence for the integrative application of Chinese herbal medicines (Chapter 5), acupuncture (Chapter 7), other Chinese medicine therapies (Chapter 8) and combination Chinese medicine therapies (Chapter 9) in the management of cancer pain, as well as analyse and evaluate the results of these studies from an evidence-based medicine perspective. Chapter 6 reviews and summarises experimental evidence for the bioactivity of commonly used Chinese herbs and their constituent compounds. The outcomes of these analyses are summarised and discussed in Chapter 10 which alsoidentifies implications for the clinical practice of Chinese medicine and for future research.This book can inform clinicians and students in the fields of integrative medicine and Chinese medicine regarding contemporary practice and the current evidence base for a range of Chinese medicine therapies used in the management of cancer pain, including herbal formulas and acupuncture treatments, in order to assist clinicians in making evidence-based decisions in patient care. It also provides researchers with a comprehensive summary of the state of the field than can inform future.The following features mark the importance of this book in the field:

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382

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World Scientific

Published Date

ISBN 10

9811237956

ISBN 13

9789811237959

Crisis Rhetoric and Policy Change in China

By: Yihong Liu

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Crisis Rhetoric and Policy Change in China

By: Yihong Liu

This book explores how China's political system responds to crisis. A crisis is an episode whose impact cannot be controlled merely by astute on-the-ground incident management, particularly in cases involving widespread doubt about the legitimacy of established policy paradigms or the political order as a whole. Crisis can create “political windows” for advocacy groups challenging established policies in pluralist democracies. The political battle between competing definitions of an uncertain and ambiguous situation among the various actors provides them with crisis-induced opportunity space for dramatic policy change. However, the process of crisis-induced policy change, mainly by crisis framing, in non-west regimes like China has not been adequately addressed. As China's leadership foregrounds legitimacy in “victory” over COVID-19, and a new era of climate change disasters begins, this dynamic model of crisis and recuperation will offer food for thought for scholars of Chinese and global politics.

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266

Publisher

Springer Nature

Published Date

ISBN 10

9811677638

ISBN 13

9789811677632

Not Just a Man’s War

Chinese Women’s Memories of the War of Resistance against Japan, 1931–45

By: Yihong Pan

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Not Just a Man’s War

Chinese Women’s Memories of the War of Resistance against Japan, 1931–45

By: Yihong Pan

In 1931, Japan began a brutal occupation of Manchuria, and in 1937, China and Japan entered a full-scale war that ended with Japan’s defeat in 1945. The War of Resistance became the Chinese experience of the Second World War. Yet women scarcely get a mention in most accounts of the fourteen-year conflict. Through interviews, published reminiscences, and oral histories, Not Just a Man’s War uncovers the extraordinary stories of ordinary Chinese women during the war. Communist women speak of fighting as soldiers for “a good war” and contributing to the party’s rise to power. Nationalist women attribute their survival to the strength of the human spirit while acknowledging tremendous suffering. Women from the working poor and the middle classes describe the hardships of Japanese aggression and in their narratives refuse to be ignored as passive beings. In speaking up, the victims of sexual violence become survivor activists demanding justice. These women demonstrate a striking autonomy regardless of political association, socioeconomic status, or education. By attending to their insights, Not Just a Man’s War produces a multi-faceted, inclusive narrative of China’s War of Resistance.

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281

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UBC Press

Published Date

ISBN 10

0774870389

ISBN 13

9780774870382

Genomic Biomarkers for Pharmaceutical Development

Chapter 3. Personalized Healthcare in Autoimmune Diseases

By: Cornelis L. Verweij,Brandon W. Higgs,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 3. Personalized Healthcare in Autoimmune Diseases

By: Cornelis L. Verweij,Brandon W. Higgs,Yihong Yao

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Elsevier Inc. Chapters

Published Date

ISBN 10

0128063521

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9780128063521

Genomic Biomarkers for Pharmaceutical Development

Chapter 1. Application of Translational Science to Clinical Development

By: Koustubh Ranade,Brandon W. Higgs,Ruth March,Lorin Roskos,Bahija Jallal,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 1. Application of Translational Science to Clinical Development

By: Koustubh Ranade,Brandon W. Higgs,Ruth March,Lorin Roskos,Bahija Jallal,Yihong Yao

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0128063505

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9780128063507

Genomic Biomarkers for Pharmaceutical Development

Chapter 7. Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration

By: Philip Brohawn,Brandon W. Higgs,Koustubh Ranade,Bahija Jallal,Yihong Yao

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Genomic Biomarkers for Pharmaceutical Development

Chapter 7. Translating Biomarker Discovery into Companion Diagnostics through Validation and Regulatory Consideration

By: Philip Brohawn,Brandon W. Higgs,Koustubh Ranade,Bahija Jallal,Yihong Yao

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0128063564

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9780128063569

Book's by Yihong Yao

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Evidence-based Clinical Chinese Medicine - Volume 17: Colorectal Cancer

Evidence-based Clinical Chinese Medicine - Volume 17: Colorectal Cancer

Evidence-based Clinical Chinese Medicine - Volume 18: Cancer Pain

Evidence-based Clinical Chinese Medicine - Volume 18: Cancer Pain

Crisis Rhetoric and Policy Change in China

Crisis Rhetoric and Policy Change in China

Not Just a Man’s War

Not Just a Man’s War

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

Genomic Biomarkers for Pharmaceutical Development

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