Published December, 2020
By Ding-Geng (Din) Chen, Karl E. Peace and Pinggao Zhang
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

This book will provide a thorough presentation of clinical trial methodology with detailed step-by-step illustrations on implementation in software R/SAS. The examples will be based on actual experience of the authors in many areas of clinical drug development. Actual examples of clinical trials will be presented and after understanding the appl

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Published December, 2020
By Hui Quan and Joshua Chen
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

This book presents a comprehensive overview on the current status of conducting MRCTs in clinical development. It first provides a high-level introduction to the context, motivation, opportunities, and challenges in simultaneous global clinical development using MRCTs. It then focuses on the design, monitoring, and analysis/interpretation of MRC

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Published December, 2020
By Mohamed M. Shoukri
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

Presenting in depth discussions of various statistical models and methods needed for the analysis of medical, biological and biostatistics data, this book emphasizes the analysis of data when normal distribution assumptions are not tenable. It provides detailed explanations in situations when data are naturally clustered in groups, whereby the I

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Published December, 2020
By Shein-Chung Chow
Publisher: Taylor & Francis (CRC Press)
Rating: 1.00
Availability: Available

Focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It will cover current issues, and recent development in analytical similarity assessment.

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Published December, 2020
By Elias Moreno, Francisco Jose Vazquez-Polo and Miguel Angel Negrin-Hernandez
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

This book deals with the statistical analysis of the cost-effectiveness of medical treatments.

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Published December, 2020
By Wei Zhao, Harry Yang, Jianchun Zhang and Binbing Yu
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

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. Along with covering regulatory requirements, the authors discuss statisti

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Published December, 2020
By Weili He and Qi Jiang
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

This book provides guidance on selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission. The

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Published December, 2020
By Chunxiang Cao, Min Xu, Patcharin Kamsing, Sornkitja Boonprong, Peera Yomwan and Apitach Saokarn
Publisher: Springer (Springer Verlag, Singapore)
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Availability: Available

This book introduces flood inundation area and flood risks assessment based on a comprehensive monitoring system using remote sensing and geographic information system technologies.

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Published December, 2020
By Thomas V. Inglesby and Amesh A. Adalja
Publisher: Springer (Springer Nature Switzerland AG)
Rating:
Availability: Available

This volume focuses on Global Catastrophic Biological Risks (GCBRs), a special class of infectious disease outbreaks or pandemics in which the combined capacity of the world's private and government resources becomes severely strained.

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Published December, 2020
By Zhengming Chen
Publisher: Springer (Springer Verlag, Singapore)
Rating:
Availability: Available

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