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Statistical Issues in Drug Development The revised third edition of Statistical Issues in Drug Development delivers an insightful treatment;
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of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug;
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of the work groups, the work group guidelines and structure, and the statistical issues associated with clinical trials in clinical drug;
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study designs and statistical methods for rare diseases drug development including n-of-1 trial design, adaptive trial design, and master;
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study designs and statistical methods for rare diseases drug development including n-of-1 trial design, adaptive trial design, and master;
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Evaluation of Safety in Drug Development: Design, Analysis and Reporting explains design, monitoring, analysis, and reporting issues for both;
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changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory;
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changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory;
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The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical;
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The growing interest in using combination drugs to treat various complex diseases has spawned the development of many novel statistical;
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in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease TreatmentThe first four;
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in drug discovery and preclinical and clinical development. Robust Biomarkers for Drug Development and Disease TreatmentThe first four;
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provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations;
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provided by Outsourcing in Clinical Drug Development. A panel of experts discuss supplier identification and selection, financial considerations;
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Innovative Methods for Rare Diseases Drug Development focuses on biostatistical applications in terms of design and analysis;
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SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations;
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drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and clinical/medical;
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stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for;
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stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for;
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. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are;
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target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical;
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of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory;
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of Statistical Sciences at AstraZeneca. He has 24 years of experience across all aspects of drug research and development and extensive global regulatory;
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This contributed volume offers a much-needed overview of the statistical methods in early clinical drug and biomarker development. Chapters;
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Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics;
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Emphasizing the role of good statistical practices (GSP) in drug research and formulation, this book outlines important statistics;
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field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range;
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