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Clinical Trial Simulations
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2521328Clinical Trial Simulationshttps://www.gandhi.com.mx/clinical-trial-simulations-9781441974150/phttps://gandhi.vtexassets.com/arquivos/ids/3334775/aefa055b-a202-4db4-9375-dba990c51af8.jpg?v=63838522518897000038844315MXNSpringer New YorkInStock/Ebooks/<p>This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.</p>...2457465Clinical Trial Simulations38844315https://www.gandhi.com.mx/clinical-trial-simulations-9781441974150/phttps://gandhi.vtexassets.com/arquivos/ids/3334775/aefa055b-a202-4db4-9375-dba990c51af8.jpg?v=638385225188970000InStockMXN99999DIEbook20109781441974150_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_<p>There have been tremendous advancements in application of modeling and simulation (M&S) in drug development during the last decade. The pharmaceutical companies started to pay more attention to implement simulation exercises in drug development in order to achieve cost effectiveness. The Food and Drug Administration (FDA) published a white paper titled, Critical Path Initiatives, in March 2004. This puts forward model based drug development that calls for use of quantitative M&S to facilitate informed decisions. The European Medicines Agency (EMEA) also encourages use of simulations in guiding drug development. With this much interest, <em>Clinical Trial Simulations</em> will serve as a reference to understand how clinical trial simulations are being used in drug development. <em>Clinical Trial Simulations</em> compiles the topics of recent interest and the case studies of how clinical trial simulations were used in various therapeutic areas. It is divided into parts that describe subjects that have gained interest recently; application of M&S in regulatory decisions; application of M&S in various therapeutic areas; and special use of M&S.</p>...(*_*)9781441974150_<p>This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.</p>...9781441974150_Springer New Yorklibro_electonico_b9d10906-024b-3368-b458-7647a69ba8cf_9781441974150;9781441974150_9781441974150InglésMéxico2010-12-09T00:00:00+00:00Springer New York