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An essential, up-to-date guide to the design of studies and selection of the... Læs mere
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Methods and Applications of Statistics in Clinical Trials, Volume 2: Planning, Analysis, and... Læs mere
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This comprehensive book features both new and established material on the key statistical principles and concepts for designing modern-day clinical trials, such as hazard ratio, flexible designs, confounding, covariates, missing data, and longitudinal data.
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Clinical trials are conducted to allow safety and efficacy data to be collected for health interventions. These trials can only take place once satisfactory information has been gathered on the quality of the non-clinical safety.
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Design, Execution, and Management of Medical Device Clinical Trials provides practical examples, ranging from the development of clinical protocol and the selection of clinical sites and ending with the completion of the final clinical report study.
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A balanced treatment of the theories, methodologies, and design issues involved in clinical trials using statistical methods There has been enormous interest and development in Bayesian adaptive designs, especially for early phases of clinical trials.
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This book with CD-ROM introduces the Software ExpDesign Studio for classic and adaptive designs and computer simulations. The book... Læs mere
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This book provides a systematic and organized approach to analyzing data for a RCT with noncompliance under the most... Læs mere
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Details how advances and demands for safety and efficacy have changed the process by which drugs are developed and approved. This work examines critical... Læs mere
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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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The proposed book will focus on practical issues in pharmaceutical/clinical research and development from both regulatory and scientific perspectives. The book will outline and clarify those issues that have been commonly misused in the subject area of regulatory science.