Innovative Statistics In Regulatory Science
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Innovative Statistics In Regulatory Science
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Author : Shein-Chung Chow
language : en
Publisher: CRC Press
Release Date : 2019-11-14
Innovative Statistics In Regulatory Science written by Shein-Chung Chow and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-14 with Mathematics categories.
Statistical methods that are commonly used in the review and approval process of regulatory submissions are usually referred to as statistics in regulatory science or regulatory statistics. In a broader sense, statistics in regulatory science can be defined as valid statistics that are employed in the review and approval process of regulatory submissions of pharmaceutical products. In addition, statistics in regulatory science are involved with the development of regulatory policy, guidance, and regulatory critical clinical initiatives related research. This book is devoted to the discussion of statistics in regulatory science for pharmaceutical development. It covers practical issues that are commonly encountered in regulatory science of pharmaceutical research and development including topics related to research activities, review of regulatory submissions, recent critical clinical initiatives, and policy/guidance development in regulatory science. Devoted entirely to discussing statistics in regulatory science for pharmaceutical development. Reviews critical issues (e.g., endpoint/margin selection and complex innovative design such as adaptive trial design) in the pharmaceutical development and regulatory approval process. Clarifies controversial statistical issues (e.g., hypothesis testing versus confidence interval approach, missing data/estimands, multiplicity, and Bayesian design and approach) in review/approval of regulatory submissions. Proposes innovative thinking regarding study designs and statistical methods (e.g., n-of-1 trial design, adaptive trial design, and probability monitoring procedure for sample size) for rare disease drug development. Provides insight regarding current regulatory clinical initiatives (e.g., precision/personalized medicine, biomarker-driven target clinical trials, model informed drug development, big data analytics, and real world data/evidence). This book provides key statistical concepts, innovative designs, and analysis methods that are useful in regulatory science. Also included are some practical, challenging, and controversial issues that are commonly seen in the review and approval process of regulatory submissions. About the author Shein-Chung Chow, Ph.D. is currently a Professor at Duke University School of Medicine, Durham, NC. He was previously the Associate Director at the Office of Biostatistics, Center for Drug Evaluation and Research, United States Food and Drug Administration (FDA). Dr. Chow has also held various positions in the pharmaceutical industry such as Vice President at Millennium, Cambridge, MA, Executive Director at Covance, Princeton, NJ, and Director and Department Head at Bristol-Myers Squibb, Plainsboro, NJ. He was elected Fellow of the American Statistical Association and an elected member of the ISI (International Statistical Institute). Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Biostatistics Book Series, Chapman and Hall/CRC Press, Taylor & Francis, New York. Dr. Chow is the author or co-author of over 300 methodology papers and 30 books.
Pharmaceutical Regulatory Science
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Author : Dr. Rajinder Mann
language : en
Publisher: Thakur Publication Private Limited
Release Date : 2021-03-09
Pharmaceutical Regulatory Science written by Dr. Rajinder Mann and has been published by Thakur Publication Private Limited this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-03-09 with Medical categories.
Purchase the e-Book version of ‘Pharmaceutical Regulatory Science' for B.Pharm 8th Semester, meticulously aligned with the PCI Syllabus. Published by Thakur Publication, this digital edition offers a comprehensive exploration of advanced instrumentation techniques at your fingertips. Upgrade your learning experience with the convenience and portability of an e-Book. Dive into the world of cutting-edge pharmaceutical instrumentation with ease. Get your copy today and embark on a journey of enhanced understanding.
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2012-04-04
Strengthening A Workforce For Innovative Regulatory Science In Therapeutics Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-04 with Medical categories.
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
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.
Insights In Regulatory Science 2021
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Author : Bruno Sepodes
language : en
Publisher: Frontiers Media SA
Release Date : 2022-11-04
Insights In Regulatory Science 2021 written by Bruno Sepodes and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-11-04 with Medical categories.
Innovative Designs And Analyses For Small Population Clinical Trials
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Author : Jingjing Ye
language : en
Publisher: Springer Nature
Release Date : 2024-11-19
Innovative Designs And Analyses For Small Population Clinical Trials written by Jingjing Ye and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-19 with Medical categories.
This book discusses a multidisciplinary and multi-stakeholder collaborative approach to small population clinical trials. It provides and illustrates a systematic framework that depends upon a collaborative infrastructure between the patient community, patient advocacy groups, researchers and investigators, pharmaceutical companies, global regulatory agencies, and customers. The book also highlights the considerations of natural history and patient registry, diagnostic criteria determination, identification of clinically meaningful endpoints, and global regulatory guidance. The authors detail the nuances of clinical trial design as specific to small population disease, drawing from real examples.
Statistical Applications From Clinical Trials And Personalized Medicine To Finance And Business Analytics
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Author : Jianchang Lin
language : en
Publisher: Springer
Release Date : 2016-11-13
Statistical Applications From Clinical Trials And Personalized Medicine To Finance And Business Analytics written by Jianchang Lin and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-11-13 with Medical categories.
The papers in this volume represent a broad, applied swath of advanced contributions to the 2015 ICSA/Graybill Applied Statistics Symposium of the International Chinese Statistical Association, held at Colorado State University in Fort Collins. The contributions cover topics that range from statistical applications in business and finance to applications in clinical trials and biomarker analysis. Each papers was peer-reviewed by at least two referees and also by an editor. The conference was attended by over 400 participants from academia, industry, and government agencies around the world, including from North America, Asia, and Europe.
Statistics In The 21st Century
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Author : Adrian E. Raftery
language : en
Publisher: CRC Press
Release Date : 2001-07-09
Statistics In The 21st Century written by Adrian E. Raftery and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2001-07-09 with Mathematics categories.
This volume discusses an important area of statistics and highlights the most important statistical advances. It is divided into four sections: statistics in the life and medical sciences, business and social science, the physical sciences and engineering, and theory and methods of statistics.
Enhanced Access To Publicly Funded Data For Science Technology And Innovation
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Author : OECD
language : en
Publisher: OECD Publishing
Release Date : 2020-04-30
Enhanced Access To Publicly Funded Data For Science Technology And Innovation written by OECD and has been published by OECD Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-30 with categories.
This report presents current policy practice to promote access to publicly funded data for science, technology and innovation, as well as policy challenges for the future. It examines national policies and international initiatives, and identifies seven issues that require policy attention.
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.