Biopharmaceutical Applied Statistics Symposium, Karl E. Peace; Ding-Geng Chen; Sandeep Menon
Автор: Pham Phuc Van Название: Stem Cell Drugs - A New Generation of Biopharmaceuticals ISBN: 3319993275 ISBN-13(EAN): 9783319993270 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This invaluable resource discusses the current revolution in stem cell-based drugs and their potential use in clinical applications. Each chapter is contributed by a pre-eminent scientist in the field. An introductory section presents current stem cell drugs and stem cell-based products and a discussion of production, quality control, mechanisms, and efficacy. Following sections include discussions on stem cell-derived microvesicles based products, and derived exosomes based products.
Stem Cell Drugs - A New Generation of Biopharmaceuticals and the other books in the Stem Cells in Clinical Applications series are invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering. This groundbreaking volume is also essential reading for those researching or studying drug development or pharmaceutical science.
Автор: Karl E. Peace; Ding-Geng Chen; Sandeep Menon Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811340080 ISBN-13(EAN): 9789811340086 Издательство: Springer Рейтинг: Цена: 13275.00 р. Наличие на складе: Поставка под заказ.
Описание:
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-vol
ume 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.
Автор: Peace Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811078254 ISBN-13(EAN): 9789811078255 Издательство: Springer Рейтинг: Цена: 15372.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: On Statistical Approaches to Meta-analysis of Randomized Clinical Trials.- Collaborative Targeted Maximum Likelihood Estimation to Assess Causal Effects in Observational Studies.- Generalized Tests in Clinical Trials.- Discrete Time-to-event and Score-based Methods with Application to Composite Endpoint for Assessing Evidence of Disease Activity-Free.- Imputing Missing Data Using a Surrogate Biomarker: Analyzing the Incidence of Endometrial Hyperplasia.- Some Statistical Issues in Patient-reported Outcomes.- Network Meta-analysis.- Detecting Safety Signals Among Adverse Events in Clinical Trials.- Applied Meta-analysis using R.- Treatment of Missing Data in Comparative Effectiveness Research.- Missing Data.- Bayesian Subgroup Analysis with Examples.- Statistical Methods in Diagnostic Devices.- A Question-Based Approach to the Analysis of Safety Data.- Analysis of Two-stage Adaptive Seamless Trial Design.- Multiplicity Problems in Clinical Trials - A Regulatory Perspective.
Автор: Karl E. Peace; Ding-Geng Chen; Sandeep Menon Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811340064 ISBN-13(EAN): 9789811340062 Издательство: Springer Рейтинг: Цена: 13275.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
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 third of the 3-volume book series. The topics covered include: Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints, Uses of Mixture Normal Distribution in Genomics and Otherwise, Personalized Medicine – Design Considerations, Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials, High Dimensional Data in Genomics; Synergy or Additivity - The Importance of Defining the Primary Endpoint, Full Bayesian Adaptive Dose Finding Using Toxicity Probability Interval (TPI), Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials, Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals, Randomized Clinical Trials for Orphan Drug Development, Mediation Modeling in Randomized Trials with Non-normal Outcome Variables, Statistical Considerations in Using Images in Clinical Trials, Interesting Applications over 30 Years of Consulting, Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials, Development and Evaluation of High Dimensional Prognostic Models, and Design and Analysis of Biosimilar Studies.
Автор: Peace Название: Biopharmaceutical Applied Statistics Symposium ISBN: 9811078289 ISBN-13(EAN): 9789811078286 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 1. A Statistical Approach to Clinical Trial Simulations.- 2. Comparison of Statistical Analysis Methods Using Modeling and Simulation for Optimal Protocol Design.- 3. Adaptive Trial Design in Clinical Research.- 4. Best Practices and Recommendations for Trial Simulations Within the Context of Designing Adaptive Clinical Trials.- 5. Designing and Analyzing Recurrent Event Data Trials.- 6. Bayesian Methodologies for Response-Adaptive Allocation.- 7. Addressing High Placebo Response in Neuroscience Clinical Trials.- 8. Phase I Cancer Clinical Trial Design: Single and Combination Agents.- 9. Sample Size and Power for the Mixed Linear Model.- 10. Crossover Designs.- 11. Data monitoring: Structure for Clinical Trials and Sequential Monitoring Procedures.- 12. Design and Data Analysis of Multiregional Clinical Trials (MRCT) - Theory and Practice.- 13. Multiregional Clinical Trials (MRCT).- 14. Adaptive Group-Sequential Multi-regional Outcome Studies in Vaccines.- 15. Development and validation of Patient-reported Outcomes.- 16. Interim Analysis of Survival Trials: Group Sequential Analyses and Conditional Power.
Автор: Lanju Zhang; Ding-Geng (Din) Chen; Hongmei Jiang; Название: Contemporary Biostatistics with Biopharmaceutical Applications ISBN: 3030153096 ISBN-13(EAN): 9783030153090 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications.Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.
Автор: Sergio Rosales-Mendoza Название: Algae-Based Biopharmaceuticals ISBN: 3319322303 ISBN-13(EAN): 9783319322308 Издательство: Springer Рейтинг: Цена: 19591.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book constitutes a key reference on the use of algae in the biopharmaceuticals production field; First, the features of algae as convenient hosts for the production of BFs are analyzed in terms of production costs, biosynthetic capacity, and safety (Chapter 1).
Автор: Phuc Van Pham Название: Stem Cell Drugs - A New Generation of Biopharmaceuticals ISBN: 3030075893 ISBN-13(EAN): 9783030075897 Издательство: Springer Рейтинг: Цена: 15372.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This invaluable resource discusses the current revolution in stem cell-based drugs and their potential use in clinical applications. Each chapter is contributed by a pre-eminent scientist in the field. An introductory section presents current stem cell drugs and stem cell-based products and a discussion of production, quality control, mechanisms, and efficacy. Following sections include discussions on stem cell-derived microvesicles based products, and derived exosomes based products.
Stem Cell Drugs - A New Generation of Biopharmaceuticals and the other books in the Stem Cells in Clinical Applications series are invaluable to scientists, researchers, advanced students and clinicians working in stem cells, regenerative medicine or tissue engineering. This groundbreaking volume is also essential reading for those researching or studying drug development or pharmaceutical science.
Автор: Karl E. Peace; Ding-Geng Chen; Sandeep Menon Название: Biopharmaceutical Applied Statistics Symposium ISBN: 981107819X ISBN-13(EAN): 9789811078194 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Part I: Personalized Medicine.- 1 Targeted Learning of Optimal Individualized Treatment Rules under Cost Constraints.- 2 Uses of Mixture Normal Distribution in Genomics and Otherwise.- 3 Personalized Medicine - Design Considerations.- 4 Adaptive Biomarker Subpopulation and Tumor Type Selection in Phase III Oncology Trials.- 5 High Dimensional Data in Genomics.- Part II: Novel Applications.- 6 Synergy or Additivity - The Importance of Defining the Primary Endpoint.- 7 Full Bayesian Adaptive Dose Finding using Toxicity Probability Interval (TPI).- 8 Alpha-recycling for the Analyses of Primary and Secondary Endpoints of Clinical Trials.- 9 Expanded Interpretations of Results of Carcinogenicity Studies of Pharmaceuticals.- 1 Clinical Trials in Orphan Drug Development.- 11 Mediation Modeling in Randomized Trials with Non-normal Outcome Variables.- 12 Statistical Considerations in Using Images in Clinical Trials.- 13 Interesting Applications over 30 Years of Consulting.- 14 Uncovering Fraud, Misconduct and Other Data Quality Issues in Clinical Trials.- 15 Development and Evaluation of High Dimensional Prognostic Models.- 16 Design and Analysis of Biosimilar Studies.
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