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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: 24.72 MB
Format: PDF, Docs
Category : Medical
Languages : en
Pages : 540
View: 2377

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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: 45.12 MB
Format: PDF, ePub
Category : Medical
Languages : en
Pages : 424
View: 6501

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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 Using R

Clinical Trial Simulations Using R PDF
Author: Seth Berry
Publisher:
Release: 2017
ISBN: 9781315120799
Size: 13.36 MB
Format: PDF, ePub, Mobi
Category : MEDICAL
Languages : en
Pages : 508
View: 4817

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Clinical Trial Simulations Using R

by Seth Berry, Clinical Trial Simulations Using R Books available in PDF, EPUB, Mobi Format. Download Clinical Trial Simulations Using R books,



Clinical Trial Simulations

Clinical Trial Simulations PDF
Author: Sandeep M. Menon
Publisher: CRC Press
Release: 2015-12-26
ISBN: 9781482233094
Size: 70.59 MB
Format: PDF, Mobi
Category : Mathematics
Languages : en
Pages : 200
View: 1283

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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.



Kundennutzen Durch Digitale Transformation

Kundennutzen durch digitale Transformation PDF
Author: Elke Brucker-Kley
Publisher: Springer-Verlag
Release: 2018-04-17
ISBN: 366255707X
Size: 21.20 MB
Format: PDF, Mobi
Category : Business & Economics
Languages : de
Pages : 153
View: 1895

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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.



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: 2019-03-29
ISBN: 1351214527
Size: 63.20 MB
Format: PDF, ePub
Category : Mathematics
Languages : en
Pages : 362
View: 804

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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.



Physiologically Based Pharmacokinetic Pbpk Modeling And Simulations

Physiologically Based Pharmacokinetic  PBPK  Modeling and Simulations PDF
Author: Sheila Annie Peters
Publisher: John Wiley & Sons
Release: 2012-02-17
ISBN: 1118140303
Size: 37.28 MB
Format: PDF, Mobi
Category : Medical
Languages : en
Pages : 450
View: 2507

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Physiologically Based Pharmacokinetic Pbpk Modeling And Simulations

by Sheila Annie Peters, Physiologically Based Pharmacokinetic Pbpk Modeling And Simulations Books available in PDF, EPUB, Mobi Format. Download Physiologically Based Pharmacokinetic Pbpk Modeling And Simulations books, The only book dedicated to physiologically-based pharmacokineticmodeling in pharmaceutical science Physiologically-based pharmacokinetic (PBPK) modeling has becomeincreasingly widespread within the pharmaceutical industry over thelast decade, but without one dedicated book that provides theinformation researchers need to learn these new techniques, itsapplications are severely limited. Describing the principles,methods, and applications of PBPK modeling as used inpharmaceutics, Physiologically-Based Pharmacokinetic (PBPK)Modeling and Simulations fills this void. Connecting theory with practice, the book explores theincredible potential of PBPK modeling for improving drug discoveryand development. Comprised of two parts, the book first provides adetailed and systematic treatment of the principles behindphysiological modeling of pharmacokinetic processes,inter-individual variability, and drug interactions for smallmolecule drugs and biologics. The second part looks in greaterdetail at the powerful applications of PBPK to drug research. Designed for a wide audience encompassing readers looking for abrief overview of the field as well as those who need more detail,the book includes a range of important learning aids. Featuringend-of-chapter keywords for easy reference—a valuable assetfor general or novice readers without a PBPK background—alongwith an extensive bibliography for those looking for furtherinformation, Physiologically- Based Pharmacokinetic (PBPK) Modelingand Simulations is the essential single-volume text on one of thehottest topics in the pharmaceutical sciences today.



Encyclopedia Of Biopharmaceutical Statistics Four Volume Set

Encyclopedia of Biopharmaceutical Statistics   Four Volume Set PDF
Author: Shein-Chung Chow
Publisher: CRC Press
Release: 2018-09-03
ISBN: 1351110268
Size: 39.35 MB
Format: PDF
Category : Medical
Languages : en
Pages : 2780
View: 3780

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Encyclopedia Of Biopharmaceutical Statistics Four Volume Set

by Shein-Chung Chow, Encyclopedia Of Biopharmaceutical Statistics Four Volume Set Books available in PDF, EPUB, Mobi Format. Download Encyclopedia Of Biopharmaceutical Statistics Four Volume Set books, Since the publication of the first edition in 2000, there has been an explosive growth of literature in biopharmaceutical research and development of new medicines. This encyclopedia (1) provides a comprehensive and unified presentation of designs and analyses used at different stages of the drug development process, (2) gives a well-balanced summary of current regulatory requirements, and (3) describes recently developed statistical methods in the pharmaceutical sciences. Features of the Fourth Edition: 1. 78 new and revised entries have been added for a total of 308 chapters and a fourth volume has been added to encompass the increased number of chapters. 2. Revised and updated entries reflect changes and recent developments in regulatory requirements for the drug review/approval process and statistical designs and methodologies. 3. Additional topics include multiple-stage adaptive trial design in clinical research, translational medicine, design and analysis of biosimilar drug development, big data analytics, and real world evidence for clinical research and development. 4. A table of contents organized by stages of biopharmaceutical development provides easy access to relevant topics. About the Editor: Shein-Chung Chow, Ph.D. is currently an Associate Director, Office of Biostatistics, U.S. Food and Drug Administration (FDA). Dr. Chow is an Adjunct Professor at Duke University School of Medicine, as well as Adjunct Professor at Duke-NUS, Singapore and North Carolina State University. Dr. Chow is the Editor-in-Chief of the Journal of Biopharmaceutical Statistics and the Chapman & Hall/CRC Biostatistics Book Series and the author of 28 books and over 300 methodology papers. He was elected Fellow of the American Statistical Association in 1995.



Wiley Encyclopedia Of Clinical Trials

Wiley Encyclopedia of Clinical Trials PDF
Author: Lisa Marie Sullivan
Publisher: Wiley-Interscience
Release: 2008
ISBN:
Size: 29.35 MB
Format: PDF, Kindle
Category : Reference
Languages : en
Pages : 1374
View: 4618

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Wiley Encyclopedia Of Clinical Trials

by Lisa Marie Sullivan, Wiley Encyclopedia Of Clinical Trials Books available in PDF, EPUB, Mobi Format. Download Wiley Encyclopedia Of Clinical Trials books, Here you'll find more than 500 entries from the world's leading experts in the field on the basic concepts, methodologies, and applications in clinical trials. The range of topics includes: basic statistical concepts, design and analysis of clinical trials, ethics, regulatory issues, and methodologies for clinical data management and analysis



Developments In Statistical Evaluation Of Clinical Trials

Developments in Statistical Evaluation of Clinical Trials PDF
Author: Kees van Montfort
Publisher: Springer
Release: 2014-10-07
ISBN: 3642553451
Size: 60.89 MB
Format: PDF, ePub, Docs
Category : Mathematics
Languages : en
Pages : 361
View: 3569

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Developments In Statistical Evaluation Of Clinical Trials

by Kees van Montfort, Developments In Statistical Evaluation Of Clinical Trials Books available in PDF, EPUB, Mobi Format. Download Developments In Statistical Evaluation Of Clinical Trials books, This book describes various ways of approaching and interpreting the data produced by clinical trial studies, with a special emphasis on the essential role that biostatistics plays in clinical trials. Over the past few decades the role of statistics in the evaluation and interpretation of clinical data has become of paramount importance. As a result the standards of clinical study design, conduct and interpretation have undergone substantial improvement. The book includes 18 carefully reviewed chapters on recent developments in clinical trials and their statistical evaluation, with each chapter providing one or more examples involving typical data sets, enabling readers to apply the proposed procedures. The chapters employ a uniform style to enhance comparability between the approaches.