Ye jingjing (42 resultados)

Condición: As New. Unread book in perfect condition.

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Condición: As New. Unread book in perfect condition.

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Taschenbuch. Condición: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development.Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs.The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development.…

Taschenbuch. Condición: Neu. Innovative Designs and Analyses for Small Population Clinical Trials | Development Strategies and Operational Engagement for Pediatric and Rare Diseases | Jingjing Ye (u. a.) | Taschenbuch | ICSA Book Series in Statistics | xix | Englisch | 2025 | Springer | EAN 9783031608452 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.…

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HRD. Condición: New. New Book. Shipped from UK. Established seller since 2000.

Taschenbuch. Condición: Neu. Dose Finding and Beyond in Biopharmaceutical Development | Jingjing Ye (u. a.) | Taschenbuch | ICSA Book Series in Statistics | xvii | Englisch | 2025 | Springer | EAN 9783031671128 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.…

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Condición: New. 2024th edition NO-PA16APR2015-KAP.

Condición: New. Ruixiao LuDr. Ruixiao Lu is a recognized leader in the biotech and biopharma industry, currently serving as Vice President, Head of Biostatistics &amp Statistical Programming at Alumis Inc. She has held senior leadership roles at various c.

Buch. Condición: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book covers topics in 2 parts: 1) Review of FDA Guidance, 2) Novel Designs and Analyses. While covering basic principles of dose finding, this book details advancements made in drug development.Finding the right dose(s) is one of the most important objectives in new drug development. In Phase I clinical development, one of the objectives is to escalate test doses from low to high. The low doses should be safe, then escalate up to the maximally tolerable dose (MTD). Phase clinical trials then lower test doses to the minimal efficacious dose (MinED). Dose range of a study drug can be thought of as the doses between MinED and MTD. From this dose range, one or a few doses are selected for Phase confirmation. In practice, dose finding is a very difficult in every phase of clinical development for new drugs.The editors brought distinguished researchers and practitioners in biopharmaceuticals and universities, to discuss the statistical procedures, useful methods, and their novel applications in dose finding. The chapters in the book present emerging topics in dose-finding and related interdisciplinary areas. This timely book is a valuable resource to stimulate the development of this growing and exciting field in drug development. …

Hardcover. Condición: Brand New. 480 pages. 9.18x6.12x9.45 inches. In Stock.

Buch. Condición: Neu. Neuware - Drug development is at a crossroads. As personalized medicine and targeted therapies expand, traditional clinical trial models have become too slow, costly, and inefficient. To meet the urgent need for faster, reliable evidence generation and decision making, researchers and regulators alike have turned to innovative trial designs. Among these, master protocols stand out as a transformative approach, allowing multiple therapies, disease subtypes, or objectives to be studied under a single, integrated framework. Proven successful in oncology, COVID-19, and beyond, they improve efficiency, reduce participant exposure to ineffective treatments, and accelerate meaningful outcomes with patient centric approach, prompting regulatory guidance and global adoption.This book provides a multidisciplinary exploration of master protocol clinical trials, blending clinical, statistical, regulatory, operational, economic insights and patients perspectives. It examines both opportunities and challenges in design and implementation, and provides in-depth summary and discussion on real-world examples such as I-SPY, ROAR, and RECOVERY. A practical guide for researchers, statisticians, regulators, and industry professionals, it demonstrates how master protocols can reshape drug development and bring innovative therapies to patients faster.¿ Provides comprehensive, theoretical and practical aspects for master protocol trials¿ Includes most recent development in the master protocol clinical trials¿ Covers broad topics such as trial designs, governance oversight, software implementation, database and data pipeline, multi-regional trials, risk and benefit with operational solutions, economic considerations, regulatory perspectives, patient engagement and diversity¿ Deep dives into numerous real world case studies, their underlying thinking, challenges and success.¿ Includes global perspective in multi-regional clinical development. …

hardcover. Condición: New. NEW. SHIPS FROM MULTIPLE LOCATIONS. book.

Condición: new. Questo è un articolo print on demand.

Condición: new. Questo è un articolo print on demand.

Hardcover. Condición: new. Hardcover. Drug development is at a crossroads. As personalized medicine and targeted therapies expand, traditional clinical trial models have become too slow, costly, and inefficient. To meet the urgent need for faster, reliable evidence generation and decision making, researchers and regulators alike have turned to innovative trial designs. Among these, master protocols stand out as a transformative approach, allowing multiple therapies, disease subtypes, or objectives to be studied under a single, integrated framework. Proven successful in oncology, COVID-19, and beyond, they improve efficiency, reduce participant exposure to ineffective treatments, and accelerate meaningful outcomes with patient centric approach, prompting regulatory guidance and global adoption.This book provides a multidisciplinary exploration of master protocol clinical trials, blending clinical, statistical, regulatory, operational, economic insights and patients perspectives. It examines both opportunities and challenges in design and implementation, and provides in-depth summary and discussion on real-world examples such as I-SPY, ROAR, and RECOVERY. A practical guide for researchers, statisticians, regulators, and industry professionals, it demonstrates how master protocols can reshape drug development and bring innovative therapies to patients faster. Provides comprehensive, theoretical and practical aspects for master protocol trials Includes most recent development in the master protocol clinical trials Covers broad topics such as trial designs, governance oversight, software implementation, database and data pipeline, multi-regional trials, risk and benefit with operational solutions, economic considerations, regulatory perspectives, patient engagement and diversity Deep dives into numerous real world case studies, their underlying thinking, challenges and success. Includes global perspective in multi-regional clinical development This book provides a multidisciplinary exploration of master protocol clinical trials, blending clinical, statistical, regulatory, operational, economic insights and patients perspectives. It examines both opportunities and challenges in design and implementation, and provides in-depth summary and discussion on real-world examples. This item is printed on demand. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. …

Buch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This book discusses a multidisciplinary and multi-stakeholder collaborative approach to small population clinical trials. It provides and illustrates a systematic framework that depends upon a collaborative infrastructure between the patient community, patient advocacy groups, researchers and investigators, pharmaceutical companies, global regulatory agencies, and customers. The book also highlights the considerations of natural history and patient registry, diagnostic criteria determination, identification of clinically meaningful endpoints, and global regulatory guidance. The authors detail the nuances of clinical trial design as specific to small population disease, drawing from real examples. 473 pp. Englisch.…

Hardcover. Condición: new. Hardcover. Drug development is at a crossroads. As personalized medicine and targeted therapies expand, traditional clinical trial models have become too slow, costly, and inefficient. To meet the urgent need for faster, reliable evidence generation and decision making, researchers and regulators alike have turned to innovative trial designs. Among these, master protocols stand out as a transformative approach, allowing multiple therapies, disease subtypes, or objectives to be studied under a single, integrated framework. Proven successful in oncology, COVID-19, and beyond, they improve efficiency, reduce participant exposure to ineffective treatments, and accelerate meaningful outcomes with patient centric approach, prompting regulatory guidance and global adoption.This book provides a multidisciplinary exploration of master protocol clinical trials, blending clinical, statistical, regulatory, operational, economic insights and patients perspectives. It examines both opportunities and challenges in design and implementation, and provides in-depth summary and discussion on real-world examples such as I-SPY, ROAR, and RECOVERY. A practical guide for researchers, statisticians, regulators, and industry professionals, it demonstrates how master protocols can reshape drug development and bring innovative therapies to patients faster. Provides comprehensive, theoretical and practical aspects for master protocol trials Includes most recent development in the master protocol clinical trials Covers broad topics such as trial designs, governance oversight, software implementation, database and data pipeline, multi-regional trials, risk and benefit with operational solutions, economic considerations, regulatory perspectives, patient engagement and diversity Deep dives into numerous real world case studies, their underlying thinking, challenges and success. Includes global perspective in multi-regional clinical development This book provides a multidisciplinary exploration of master protocol clinical trials, blending clinical, statistical, regulatory, operational, economic insights and patients perspectives. It examines both opportunities and challenges in design and implementation, and provides in-depth summary and discussion on real-world examples. This item is printed on demand. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability. …

Taschenbuch. Condición: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This book discusses a multidisciplinary and multi-stakeholder collaborative approach to small population clinical trials. It provides and illustrates a systematic framework that depends upon a collaborative infrastructure between the patient community, patient advocacy groups, researchers and investigators, pharmaceutical companies, global regulatory agencies, and customers. The book also highlights the considerations of natural history and patient registry, diagnostic criteria determination, identification of clinically meaningful endpoints, and global regulatory guidance. The authors detail the nuances of clinical trial design as specific to small population disease, drawing from real examples. 496 pp. Englisch.…

Gebunden. Condición: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt. This book discusses a multidisciplinary and multi-stakeholder collaborative approach to small population clinical trials. It provides and illustrates a systematic framework that depends upon a collaborative infrastructure between the patient community, pati.…

Condición: New. Dieser Artikel ist ein Print on Demand Artikel und wird nach Ihrer Bestellung fuer Sie gedruckt.

Condición: new. Questo è un articolo print on demand.