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Translational Medicine provides scientists responsible for the translation of novel biopharmaceuticals into clinical... Læs mere
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This gives a comprehensive introduction to the (standard) statistical analysis based on the theory of martingales and develops entropy methods in order to treat... Læs mere
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A Practical Guide to Clinical Data Management, Fourth Edition provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks.
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This book provides detailed concept and information on principles and processes of signal analysis in pharmacovigilance along with case... Læs mere
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Causal Inference in Pharmaceutical Statistics introduces the basic concepts and fundamental methods of causal inference relevant to pharmaceutical statistics. This book covers causal thinking for different types of commonly used study designs in the pharmaceutical industry.
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This book focuses on leadership and management strategies including project management, budget planning and management, governance,... Læs mere
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This book contains chapters providing interpretations of principles in ICH E17 and new ideas of implementing MRCTs.... Læs mere
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Treats the topics of multiple comparisons, simultaneous and selective inference from avariety of different perspectives. The need for a systematic treatment of the eld... Læs mere
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This book provides a comprehensive coverage on safety monitoring methodologies, covering both global... Læs mere
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The book explores the early days of industry-sponsored clinical research in psychiatry. Examining how the clinic, patients, doctors, nursing staff,... Læs mere
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This book serves as a comprehensive guide on quality control and regulatory aspects for biological products. It covers a wide range of topics, including regulatory requirements, quality control strategies, analytical methods, and risk management.
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Development of Gene Therapies: Strategic, Scientific, and Regulatory, and Access Considerations attempts to summarize the current state-of-the-art strategic, scientific, statistical, and regulatory aspects of GTx development.