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Clinical Trial Simulations

Clinical Trial Simulations PDF
Author: Holly H. C. Kimko
Publisher: Springer Science & Business Media
Release: 2010-12-09
ISBN: 9781441974150
Size: 63.97 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 540
View: 2232

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Clinical Trial Simulations

by Holly H. C. Kimko, Clinical Trial Simulations Books available in PDF, EPUB, Mobi Format. Download Clinical Trial Simulations books, 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.



Simulation For Designing Clinical Trials

Simulation for Designing Clinical Trials PDF
Author: Hui Kimko
Publisher: CRC Press
Release: 2002-12-12
ISBN: 0203910273
Size: 79.60 MB
Format: PDF, ePub, Docs
Category : Medical
Languages : en
Pages : 424
View: 238

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Simulation For Designing Clinical Trials

by Hui Kimko, Simulation For Designing Clinical Trials Books available in PDF, EPUB, Mobi Format. Download Simulation For Designing Clinical Trials books, Providing more than just a comprehensive history, critical vocabulary, insightful compilation of motivations, and clear explanation of the state-of-the-art of modern clinical trial simulation, this book supplies a rigorous framework for employing simulation as an experiment, according to a predefined simulation plan, that reflects good simulation p



Clinical Trial Simulations

Clinical Trial Simulations PDF
Author: Holly H. C. Kimko
Publisher: Springer
Release: 2011-07-21
ISBN: 9781441974167
Size: 14.13 MB
Format: PDF, ePub, Mobi
Category : Medical
Languages : en
Pages : 540
View: 4583

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Clinical Trial Simulations

by Holly H. C. Kimko, Clinical Trial Simulations Books available in PDF, EPUB, Mobi Format. Download Clinical Trial Simulations books, 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.



Clinical Trial Simulations

Clinical Trial Simulations PDF
Author: Holly H. C. Kimko
Publisher: Springer
Release: 2010-12-10
ISBN: 9781441974143
Size: 80.57 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 540
View: 2438

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Clinical Trial Simulations

by Holly H. C. Kimko, Clinical Trial Simulations Books available in PDF, EPUB, Mobi Format. Download Clinical Trial Simulations books, 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.



Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials

Innovative Strategies  Statistical Solutions and Simulations for Modern Clinical Trials PDF
Author: Mark Chang
Publisher: CRC Press
Release: 2019-03-20
ISBN: 1351214535
Size: 25.42 MB
Format: PDF, ePub, Mobi
Category : Mathematics
Languages : en
Pages : 362
View: 2336

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Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials

by Mark Chang, Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials Books available in PDF, EPUB, Mobi Format. Download Innovative Strategies Statistical Solutions And Simulations For Modern Clinical Trials books, "This is truly an outstanding book. [It] brings together all of the latest research in clinical trials methodology and how it can be applied to drug development.... Chang et al provide applications to industry-supported trials. This will allow statisticians in the industry community to take these methods seriously." Jay Herson, Johns Hopkins University The pharmaceutical industry's approach to drug discovery and development has rapidly transformed in the last decade from the more traditional Research and Development (R & D) approach to a more innovative approach in which strategies are employed to compress and optimize the clinical development plan and associated timelines. However, these strategies are generally being considered on an individual trial basis and not as part of a fully integrated overall development program. Such optimization at the trial level is somewhat near-sighted and does not ensure cost, time, or development efficiency of the overall program. This book seeks to address this imbalance by establishing a statistical framework for overall/global clinical development optimization and providing tactics and techniques to support such optimization, including clinical trial simulations. Provides a statistical framework for achieve global optimization in each phase of the drug development process. Describes specific techniques to support optimization including adaptive designs, precision medicine, survival-endpoints, dose finding and multiple testing. Gives practical approaches to handling missing data in clinical trials using SAS. Looks at key controversial issues from both a clinical and statistical perspective. Presents a generous number of case studies from multiple therapeutic areas that help motivate and illustrate the statistical methods introduced in the book. Puts great emphasis on software implementation of the statistical methods with multiple examples of software code (both SAS and R). It is important for statisticians to possess a deep knowledge of the drug development process beyond statistical considerations. For these reasons, this book incorporates both statistical and "clinical/medical" perspectives.



Biopharmaceutical Applied Statistics Symposium

Biopharmaceutical Applied Statistics Symposium PDF
Author: Karl E. Peace
Publisher: Springer
Release: 2018-08-20
ISBN: 9811078297
Size: 56.87 MB
Format: PDF
Category : Medical
Languages : en
Pages : 409
View: 2245

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Biopharmaceutical Applied Statistics Symposium

by Karl E. Peace, Biopharmaceutical Applied Statistics Symposium Books available in PDF, EPUB, Mobi Format. Download Biopharmaceutical Applied Statistics Symposium books, This BASS book Series publishes selected high-quality papers reflecting recent advances in the design and biostatistical analysis of biopharmaceutical experiments – particularly biopharmaceutical clinical trials. The papers were selected from invited presentations at the Biopharmaceutical Applied Statistics Symposium (BASS), which was founded by the first Editor in 1994 and has since become the premier international conference in biopharmaceutical statistics. The primary aims of the BASS are: 1) to raise funding to support graduate students in biostatistics programs, and 2) to provide an opportunity for professionals engaged in pharmaceutical drug research and development to share insights into solving the problems they encounter.The BASS book series is initially divided into three volumes addressing: 1) Design of Clinical Trials; 2) Biostatistical Analysis of Clinical Trials; and 3) Pharmaceutical Applications. This book is the first of the 3-volume book series. The topics covered include: A Statistical Approach to Clinical Trial Simulations, Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design, Adaptive Trial Design in Clinical Research, Best Practices and Recommendations for Trial Simulations in the Context of Designing Adaptive Clinical Trials, Designing and Analyzing Recurrent Event Data Trials, Bayesian Methodologies for Response-Adaptive Allocation, Addressing High Placebo Response in Neuroscience Clinical Trials, Phase I Cancer Clinical Trial Design: Single and Combination Agents, Sample Size and Power for the Mixed Linear Model, Crossover Designs in Clinical Trials, Data Monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures, Design and Data Analysis for Multiregional Clinical Trials – Theory and Practice, Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines, Development and Validation of Patient-reported Outcomes, Interim Analysis of Survival Trials: Group Sequential Analyses, and Conditional Power – A Non-proportional Hazards Perspective.



Kundennutzen Durch Digitale Transformation

Kundennutzen durch digitale Transformation PDF
Author: Elke Brucker-Kley
Publisher: Springer-Verlag
Release: 2018-04-17
ISBN: 366255707X
Size: 13.50 MB
Format: PDF, Kindle
Category : Business & Economics
Languages : de
Pages : 153
View: 3464

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Kundennutzen Durch Digitale Transformation

by Elke Brucker-Kley, Kundennutzen Durch Digitale Transformation Books available in PDF, EPUB, Mobi Format. Download Kundennutzen Durch Digitale Transformation books, Dieses Buch ist eine Open-Access-Publikation unter einer CC BY 4.0 Lizenz. Dieses Buch präsentiert die Ergebnisse einer qualitativen und quantitativen Studie, die das Institut für Wirtschaftsinformatik in Kooperation mit dem Institut für Marketingmanagement der ZHAW School of Management and Law 2016 durchgeführt hat. Ziel der Business-Process-Management-Studie, mit der seit 2011 regelmäßig Status quo und Best Practices im deutschsprachigen Raum erhoben werden, war es, die Rolle des Prozessmanagements als Gestaltungshebel der digitalen Transformation zu beleuchten.



Clinical Trial Simulations

Clinical Trial Simulations PDF
Author: Sandeep M. Menon
Publisher: CRC Press
Release: 2015-12-26
ISBN: 9781482233094
Size: 72.36 MB
Format: PDF, Mobi
Category : Mathematics
Languages : en
Pages : 200
View: 4965

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Clinical Trial Simulations

by Sandeep M. Menon, Clinical Trial Simulations Books available in PDF, EPUB, Mobi Format. Download Clinical Trial Simulations books, In biopharmaceutical statistics, simulation plays an indispensable role. Statisticians conduct simulation studies to thoroughly characterize different statistical methodologies and to compare their performance in terms of type I error, power, sample sizes, etc. This book offers programming codes (SAS and/or R), introduction of both classical and adaptive designs, practical applications of these designs, and introduction of special clinical trial designs such as dose response studies, or biomarker informed adaptive designs.