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Focuses on analytical similarity assessment in biosimilar product development following the FDA’s recommended stepwise approach for... Læs mere
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Presenting in depth discussions of various statistical models and methods needed for the analysis of medical, biological and biostatistics data, this book... Læs mere
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This book discusses how to do routine health data analysis, typically done in SAS, in R. It assumes that the audience has some experience in this area. Many SAS... Læs mere
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This book deals with randomization in clinical trials. Currently trials use permuted blocks randomization almost exclusively. Many researchers are aware... Læs mere
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This book will provide a thorough presentation of clinical trial methodology with detailed step-by-step illustrations on implementation in software R/SAS.... Læs mere
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This book provides the application of generalized linear mixed-effects models and its related models in the... Læs mere
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This volume covers the main areas of quantitative methodology for the design and analysis of CER studies. The volume has four major sections—causal... Læs mere
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Biosimilars have the potential to change the way we think about, identify, and manage health problems. They are already... Læs mere
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Missing data in longitudinal clinical trials has justifiably been the target of considerable research. However, missing data is just one of... Læs mere
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The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a... Læs mere
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This book provides guidance on selecting specific benefit–risk (B–R) frameworks and... Læs mere
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This book presents a comprehensive overview on the current status of conducting MRCTs in clinical development. It first... Læs mere