Statistical Methods And Safety Data Analysis And Evaluation
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Statistical Methods And Safety Data Analysis And Evaluation
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Author : National Research Council (U.S.). Transportation Research Board
language : en
Publisher:
Release Date : 2004
Statistical Methods And Safety Data Analysis And Evaluation written by National Research Council (U.S.). Transportation Research Board and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Roads categories.
Statistical Methods For Evaluating Safety In Medical Product Development
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Author : A. Lawrence Gould
language : en
Publisher: John Wiley & Sons
Release Date : 2015-02-23
Statistical Methods For Evaluating Safety In Medical Product Development written by A. Lawrence Gould and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-02-23 with Medical categories.
This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code
Handbook Of Statistical Methods For Randomized Controlled Trials
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Author : KyungMann Kim
language : en
Publisher: CRC Press
Release Date : 2021-08-23
Handbook Of Statistical Methods For Randomized Controlled Trials written by KyungMann Kim and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-23 with Mathematics categories.
Statistical concepts provide scientific framework in experimental studies, including randomized controlled trials. In order to design, monitor, analyze and draw conclusions scientifically from such clinical trials, clinical investigators and statisticians should have a firm grasp of the requisite statistical concepts. The Handbook of Statistical Methods for Randomized Controlled Trials presents these statistical concepts in a logical sequence from beginning to end and can be used as a textbook in a course or as a reference on statistical methods for randomized controlled trials. Part I provides a brief historical background on modern randomized controlled trials and introduces statistical concepts central to planning, monitoring and analysis of randomized controlled trials. Part II describes statistical methods for analysis of different types of outcomes and the associated statistical distributions used in testing the statistical hypotheses regarding the clinical questions. Part III describes some of the most used experimental designs for randomized controlled trials including the sample size estimation necessary in planning. Part IV describe statistical methods used in interim analysis for monitoring of efficacy and safety data. Part V describe important issues in statistical analyses such as multiple testing, subgroup analysis, competing risks and joint models for longitudinal markers and clinical outcomes. Part VI addresses selected miscellaneous topics in design and analysis including multiple assignment randomization trials, analysis of safety outcomes, non-inferiority trials, incorporating historical data, and validation of surrogate outcomes.
Quantitative Drug Safety And Benefit Risk Evaluation
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Author : William Wang
language : en
Publisher: CRC Press
Release Date : 2021-12-30
Quantitative Drug Safety And Benefit Risk Evaluation written by William Wang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-30 with Mathematics categories.
Quantitative Methodologies and Process for Safety Monitoring and Ongoing Benefit Risk Evaluation provides a comprehensive coverage on safety monitoring methodologies, covering both global trends and regional initiatives. Pharmacovigilance has traditionally focused on the handling of individual adverse event reports however recently there had been a shift towards aggregate analysis to better understand the scope of product risks. Written to be accessible not only to statisticians but also to safety scientists with a quantitative interest, this book aims to bridge the gap in knowledge between medical and statistical fields creating a truly multi-disciplinary approach that is very much needed for 21st century safety evaluation.
Statistical Methods For Immunogenicity Assessment
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2015-07-17
Statistical Methods For Immunogenicity Assessment written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-17 with Mathematics categories.
Develop Effective Immunogenicity Risk Mitigation StrategiesImmunogenicity assessment is a prerequisite for the successful development of biopharmaceuticals, including safety and efficacy evaluation. Using advanced statistical methods in the study design and analysis stages is therefore essential to immunogenicity risk assessment and mitigation stra
Erda
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Author :
language : en
Publisher:
Release Date : 1977
Erda written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1977 with categories.
Safe Mobility
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Author : Dominique Lord
language : en
Publisher: Emerald Group Publishing
Release Date : 2018-04-18
Safe Mobility written by Dominique Lord and has been published by Emerald Group Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-04-18 with Transportation categories.
This book increases the level of knowledge on road safety contexts, issues and challenges; shares what can currently be done to address the variety of issues; and points to what needs to be done to make further gains in road safety.
Pharmacovigilance E Book
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Author : Thao Doan
language : en
Publisher: Elsevier Health Sciences
Release Date : 2024-11-20
Pharmacovigilance E Book written by Thao Doan and has been published by Elsevier Health Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-20 with Medical categories.
Written by multidisciplinary experts in the fields of pharmaceutical and patient safety, Pharmacovigilance: A Practical Approach, Second Edition, provides a succinct, easy-to-digest overview of an increasingly critical area of medical safety. From cover to cover, this concise resource offers essential information for physicians and other health care professionals, clinical researchers, and regulators who need a comprehensive, up-to-date source of information on the principles and practice of pharmacovigilance. - Presents vital, easy-to-read, cutting-edge information on patient safety, the pharmacology regulatory landscape, and the current and future use of digital technologies. - Provides up-to-date coverage of hot topics in the field, including pharmacodynamic and safety precision medicine, immunogenicity, vaccine hesitancy and safety, genetic toxicology, and adverse events. - Contains new chapters on pre-clinical safety assessment, pharmacogenetics, first-in human trials, product aggregate safety assessment, data monitoring committees, and more. - Offers new and expanded coverage of pharmacovigilance in early pre-clinical drug development through post-marketing surveillance, as well as a blueprint for training future pharmacovigilance professionals. - Includes real-world case studies to ensure content is relevant and applicable to everyday practice. - Discusses a range of topics across disciplines and how they relate to pharmacovigilance, including behavioral science, patient perspectives, and risk communication. - Any additional digital ancillary content may publish up to 6 weeks following the publication date.
Biopharmaceutical Applied Statistics Symposium
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Author : Karl E. Peace
language : en
Publisher: Springer
Release Date : 2018-08-21
Biopharmaceutical Applied Statistics Symposium written by Karl E. Peace and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-21 with Medical categories.
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 second of the 3-volume book series. The topics covered include: Statistical Approaches to the 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, Selected 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, Causal Estimands: A Common Language for 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 AdaptiveSeamless Trial Design, and Multiplicity Problems in Clinical Trials – A Regulatory Perspective.
Real World Evidence In Drug Development And Evaluation
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2021-01-11
Real World Evidence In Drug Development And Evaluation written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-11 with Mathematics categories.
Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise