Jiawei Wei (14 results)

Hardcover. Condition: Brand New. 176 pages. 10.00x8.00x1.00 inches. In Stock.

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Hardcover. Condition: new. Hardcover. This book provides a comprehensive, up-to-date, and practical introduction to the estimand framework and its application in clinical trials. Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significant shift in the design, conduct, analysis, and interpretation of clinical trials. By explicitly aligning trial objectives with the clinical question of interestand by carefully accounting for intercurrent eventsthe framework facilitates greater transparency and interpretability of trial results. In recent years, its adoption has supported improved scientific and regulatory dialogue, more targeted trial designs and analysis methods, and a better understanding of treatment effects across drug development programs.This book reflects both the conceptual underpinnings of the estimand framework and the growing body of experience gained by the scientific and regulatory community since the release of the ICH E9(R1) guideline. Emphasis is placed on practical implementation across a wide range of clinical and therapeutic settings. Part I introduces the core concepts of the framework and offers detailed guidance on how to describe estimands in clinical trial protocols and related documents.Part II presents a wide range of case studies from various therapeutic areas to support practical implementation.Part III summarizes estimand-related content from regulatory guidelines across different indications.Part IV describes statistical analysis methods and approaches for handling missing data across continuous, binary, recurrent, and time-to-event endpoints.Part V explores the use of the estimand framework in a variety of clinical trial settings.Designed for a broad audience of professionals and students involved in clinical research, this book will be particularly valuable for those engaged in the design, conduct, and analysis of clinical trials across the drug development lifecycle. It serves both as a structured introduction for those new to the field and a detailed reference for experienced professionals. Whether for academic study or practical implementation, this book is an essential resource for advancing the estimand framework and promoting more robust, informative clinical trials. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.

Hardcover. Condition: new. Hardcover. This book provides a comprehensive, up-to-date, and practical introduction to the estimand framework and its application in clinical trials. Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significant shift in the design, conduct, analysis, and interpretation of clinical trials. By explicitly aligning trial objectives with the clinical question of interestand by carefully accounting for intercurrent eventsthe framework facilitates greater transparency and interpretability of trial results. In recent years, its adoption has supported improved scientific and regulatory dialogue, more targeted trial designs and analysis methods, and a better understanding of treatment effects across drug development programs.This book reflects both the conceptual underpinnings of the estimand framework and the growing body of experience gained by the scientific and regulatory community since the release of the ICH E9(R1) guideline. Emphasis is placed on practical implementation across a wide range of clinical and therapeutic settings. Part I introduces the core concepts of the framework and offers detailed guidance on how to describe estimands in clinical trial protocols and related documents.Part II presents a wide range of case studies from various therapeutic areas to support practical implementation.Part III summarizes estimand-related content from regulatory guidelines across different indications.Part IV describes statistical analysis methods and approaches for handling missing data across continuous, binary, recurrent, and time-to-event endpoints.Part V explores the use of the estimand framework in a variety of clinical trial settings.Designed for a broad audience of professionals and students involved in clinical research, this book will be particularly valuable for those engaged in the design, conduct, and analysis of clinical trials across the drug development lifecycle. It serves both as a structured introduction for those new to the field and a detailed reference for experienced professionals. Whether for academic study or practical implementation, this book is an essential resource for advancing the estimand framework and promoting more robust, informative clinical trials. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.

Condition: New.

Hardcover. Condition: new. Hardcover. This book provides a comprehensive, up-to-date, and practical introduction to the estimand framework and its application in clinical trials. Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significant shift in the design, conduct, analysis, and interpretation of clinical trials. By explicitly aligning trial objectives with the clinical question of interestand by carefully accounting for intercurrent eventsthe framework facilitates greater transparency and interpretability of trial results. In recent years, its adoption has supported improved scientific and regulatory dialogue, more targeted trial designs and analysis methods, and a better understanding of treatment effects across drug development programs.This book reflects both the conceptual underpinnings of the estimand framework and the growing body of experience gained by the scientific and regulatory community since the release of the ICH E9(R1) guideline. Emphasis is placed on practical implementation across a wide range of clinical and therapeutic settings. Part I introduces the core concepts of the framework and offers detailed guidance on how to describe estimands in clinical trial protocols and related documents.Part II presents a wide range of case studies from various therapeutic areas to support practical implementation.Part III summarizes estimand-related content from regulatory guidelines across different indications.Part IV describes statistical analysis methods and approaches for handling missing data across continuous, binary, recurrent, and time-to-event endpoints.Part V explores the use of the estimand framework in a variety of clinical trial settings.Designed for a broad audience of professionals and students involved in clinical research, this book will be particularly valuable for those engaged in the design, conduct, and analysis of clinical trials across the drug development lifecycle. It serves both as a structured introduction for those new to the field and a detailed reference for experienced professionals. Whether for academic study or practical implementation, this book is an essential resource for advancing the estimand framework and promoting more robust, informative clinical trials. Shipping may be from our Sydney, NSW warehouse or from our UK or US warehouse, depending on stock availability.

Buch. Condition: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book provides a comprehensive, up-to-date, and practical introduction to the estimand framework and its application in clinical trials. Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significant shift in the design, conduct, analysis, and interpretation of clinical trials. By explicitly aligning trial objectives with the clinical question of interest and by carefully accounting for intercurrent events the framework facilitates greater transparency and interpretability of trial results. In recent years, its adoption has supported improved scientific and regulatory dialogue, more targeted trial designs and analysis methods, and a better understanding of treatment effects across drug development programs.This book reflects both the conceptual underpinnings of the estimand framework and the growing body of experience gained by the scientific and regulatory community since the release of the ICH E9(R1) guideline. Emphasis is placed on practical implementation across a wide range of clinical and therapeutic settings.Part I introduces the core concepts of the framework and offers detailed guidance on how to describe estimands in clinical trial protocols and related documents.Part II presents a wide range of case studies from various therapeutic areas to support practical implementation.Part III summarizes estimand-related content from regulatory guidelines across different indications.Part IV describes statistical analysis methods and approaches for handling missing data across continuous, binary, recurrent, and time-to-event endpoints.Part V explores the use of the estimand framework in a variety of clinical trial settings.Designed for a broad audience of professionals and students involved in clinical research, this book will be particularly valuable for those engaged in the design, conduct, and analysis of clinical trials across the drug development lifecycle. It serves both as a structured introduction for those new to the field and a detailed reference for experienced professionals. Whether for academic study or practical implementation, this book is an essential resource for advancing the estimand framework and promoting more robust, informative clinical trials.

Buch. Condition: Neu. This item is printed on demand - it takes 3-4 days longer - Neuware -This book provides a comprehensive, up-to-date, and practical introduction to the estimand framework and its application in clinical trials. Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significant shift in the design, conduct, analysis, and interpretation of clinical trials. By explicitly aligning trial objectives with the clinical question of interest and by carefully accounting for intercurrent events the framework facilitates greater transparency and interpretability of trial results. In recent years, its adoption has supported improved scientific and regulatory dialogue, more targeted trial designs and analysis methods, and a better understanding of treatment effects across drug development programs.This book reflects both the conceptual underpinnings of the estimand framework and the growing body of experience gained by the scientific and regulatory community since the release of the ICH E9(R1) guideline. Emphasis is placed on practical implementation across a wide range of clinical and therapeutic settings.Part I introduces the core concepts of the framework and offers detailed guidance on how to describe estimands in clinical trial protocols and related documents.Part II presents a wide range of case studies from various therapeutic areas to support practical implementation.Part III summarizes estimand-related content from regulatory guidelines across different indications.Part IV describes statistical analysis methods and approaches for handling missing data across continuous, binary, recurrent, and time-to-event endpoints.Part V explores the use of the estimand framework in a variety of clinical trial settings.Designed for a broad audience of professionals and students involved in clinical research, this book will be particularly valuable for those engaged in the design, conduct, and analysis of clinical trials across the drug development lifecycle. It serves both as a structured introduction for those new to the field and a detailed reference for experienced professionals. Whether for academic study or practical implementation, this book is an essential resource for advancing the estimand framework and promoting more robust, informative clinical trials. 508 pp. Englisch.

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

Buch. Condition: Neu. Estimands in Clinical Trials | A Practical Guide | Jiawei Wei (u. a.) | Buch | Springer Series in Pharmaceutical Statistics | xix | Englisch | 2026 | Springer | EAN 9783032021915 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu Print on Demand.

Buch. Condition: Neu. This item is printed on demand - Print on Demand Titel. Neuware -This book provides a comprehensive, up-to-date, and practical introduction to the estimand framework and its application in clinical trials. Since its introduction by the International Council for Harmonisation (ICH) through the E9(R1) guideline in 2019, the estimand framework has led to a significant shift in the design, conduct, analysis, and interpretation of clinical trials. By explicitly aligning trial objectives with the clinical question of interestand by carefully accounting for intercurrent eventsthe framework facilitates greater transparency and interpretability of trial results. In recent years, its adoption has supported improved scientific and regulatory dialogue, more targeted trial designs and analysis methods, and a better understanding of treatment effects across drug development programs.This book reflects both the conceptual underpinnings of the estimand framework and the growing body of experience gained by the scientific and regulatory community since the release of the ICH E9(R1) guideline. Emphasis is placed on practical implementation across a wide range of clinical and therapeutic settings.Part I introduces the core concepts of the framework and offers detailed guidance on how to describe estimands in clinical trial protocols and related documents.Part II presents a wide range of case studies from various therapeutic areas to support practical implementation.Part III summarizes estimand-related content from regulatory guidelines across different indications.Part IV describes statistical analysis methods and approaches for handling missing data across continuous, binary, recurrent, and time-to-event endpoints.Part V explores the use of the estimand framework in a variety of clinical trial settings.Designed for a broad audience of professionals and students involved in clinical research, this book will be particularly valuable for those engaged in the design, conduct, and analysis of clinical trials across the drug development lifecycle. It serves both as a structured introduction for those new to the field and a detailed reference for experienced professionals. Whether for academic study or practical implementation, this book is an essential resource for advancing the estimand framework and promoting more robust, informative clinical trials.Springer-Verlag KG, Sachsenplatz 4-6, 1201 Wien 508 pp. Englisch.

Condition: New. PRINT ON DEMAND.

Condition: New. Print on Demand.