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  • Real-World Evidence in Medical Product Development

    Modifié par Weili He, Yixin Fang, Hongwei Wang ...
    Collections series Mathematics and Statistics (R0)
    This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many ... En savoir plus

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  • Benefit-Risk Assessment Methods in Medical Product Development

    Bridging Qualitative and Quantitative Assessments

    Modifié par Qi Jiang, Weili He ...
    Collections series Chapman & Hall/CRC Biostatistics Series
    Guides You on the Development and Implementation of B–R EvaluationsBenefit–Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit–risk (B–R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present ... En savoir plus

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  • Practical Considerations for Adaptive Trial Design and Implementation

    Collections series Mathematics and Statistics (R0)
    This edited volume is a definitive text on adaptive clinical trial designs from creation and customization to utilization. As this book covers the full spectrum of topics involved in the adaptive designs arena, it will serve as a valuable reference for researchers working in industry, government and academia. The target audience is anyone involved in the planning and execution of clinical trials, ... En savoir plus

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  • Quantitative Decisions in Drug Development

    Collections series Mathematics and Statistics (R0)
    This book offers a high-level treatise of evidence-based decisions in drug development. Because of the inseparable relationship between designs and decisions, a good portion of this book is devoted to the design of clinical trials. The book begins with an overview of product development and regulatory approval pathways. It then discusses how to incorporate prior knowledge into study design and ... En savoir plus

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  • The Essential Guide to N-of-1 Trials in Health

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  • Modern Epidemiology

    Now in a fully revised Fourth Edition, Modern Epidemiology remains the gold standard text in this complex and evolving field. This edition continues to provide comprehensive coverage of the principles and methods for the design, analysis, and interpretation of epidemiologic research. Featuring a new format allowing space for margin notes, this edition • Reflects both the conceptual development of ... En savoir plus

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  • Critical Thinking in Clinical Research

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