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 Craig Mallinckrodt and Ilya Lipkovich
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

Missing data in longitudinal clinical trials has justifiably been the target of considerable research. However, missing data is just one of the many considerations in the analysis of longitudinal data, and focus on the data we don't have should not distract from focus on the data we do have. The statistical theory relevant to analyses of longitu

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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 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 Toshiro Tango
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

This book provides the application of generalized linear mixed-effects models and its related models in the statistical design and analysis of repeated measures adopted in randomized controlled trials. With increasing concerns about intra-patient variability of treatment effects, the traditional ANCOVA-type methods can no longer cope with these

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Published December, 2020
By Harry Yang
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A compreh

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Published December, 2020
By Susan Halabi and Stefan Michiels
Publisher: Taylor & Francis (CRC Press)
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Availability: Available

This is a textbook on the design and analysis of cancer clinical trials. It opens with a discussion of the choice of endpoints before moving onto discuss various types of trials across all phases of study, including basket trials, non-inferiority trials and multi-arm trials.

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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)
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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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