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Author : Victor C. Beal
Publisher :
ISBN 13 :
Total Pages : pages
Book Rating : 4.:/5 (631 download)
Download or read book Regulatory Statistics. [United States]. written by Victor C. Beal and published by . This book was released on 1983 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Demissie Alemayehu
Publisher : CRC Press
ISBN 13 : 1000215709
Total Pages : 173 pages
Book Rating : 4.0/5 (2 download)
Download or read book Interface between Regulation and Statistics in Drug Development written by Demissie Alemayehu and published by CRC Press. This book was released on 2020-11-11 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the critical role of statistics in the design, conduct, analysis and reporting of clinical trials or observational studies intended for regulatory purposes, numerous guidelines have been issued by regulatory authorities around the world focusing on statistical issues related to drug development. However, the available literature on this important topic is sporadic, and often not readily accessible to drug developers or regulatory personnel. This book provides a systematic exposition of the interplay between the two disciplines, including emerging themes pertaining to the acceleration of the development of pharmaceutical medicines to serve patients with unmet needs. Features: Regulatory and statistical interactions throughout the drug development continuum The critical role of the statistician in relation to the changing regulatory and healthcare landscapes Statistical issues that commonly arise in the course of drug development and regulatory interactions Trending topics in drug development, with emphasis on current regulatory thinking and the associated challenges and opportunities The book is designed to be accessible to readers with an intermediate knowledge of statistics, and can be a useful resource to statisticians, medical researchers, and regulatory personnel in drug development, as well as graduate students in the health sciences. The authors’ decades of experience in the pharmaceutical industry and academia, and extensive regulatory experience, comes through in the many examples throughout the book.
Author : Wesley Magat
Publisher : Routledge
ISBN 13 : 1135998620
Total Pages : 201 pages
Book Rating : 4.1/5 (359 download)
Download or read book Rules in the Making written by Wesley Magat and published by Routledge. This book was released on 2013-10-18 with total page 201 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rules in the Making represents an attempt to revolutionize ways of thinking about regulatory decision-making. The book tries to show that statistical methodologies can be used to determine what factors are important in the establishment of government regulation by developing a mathematical model of the regulatory process and agency behavior. The model is then tested using a case study of the Environmental Protection Agency's setting of effluent discharge standards under the Clean Water Act. Originally published in 1986
Author : Wei Zhang
Publisher : CRC Press
ISBN 13 : 1000568024
Total Pages : 501 pages
Book Rating : 4.0/5 (5 download)
Download or read book Advanced Statistics in Regulatory Critical Clinical Initiatives written by Wei Zhang and published by CRC Press. This book was released on 2022-05-25 with total page 501 pages. Available in PDF, EPUB and Kindle. Book excerpt: Advanced Statistics in Regulatory Critical Clinical Initiatives is focused on the critical clinical initiatives introduced by the 21st Century Cure Act passed by the United States Congress in December 2016. The book covers everything from the outline of the initiatives to analysis on the effect on biopharmaceutical research and development. Advanced Statistics in Regulatory Critical Clinical Initiatives provides innovative ways to resolve common challenges in statistical research of rare diseases such small sample sizes and provides guidance for combined use of data. With analysis from regulatory and scientific perspectives this book is an ideal companion for researchers in biostatistics, pharmaceutical development, and policy makers in related fields. Key Features: Provides better understanding of innovative design and analysis of each critical clinical initiatives which may be used in regulatory review/approval of drug development. Makes recommendations to evaluate submissions accurately and reliably. Proposes innovative study designs and statistical methods for oncology and/or rare disease drug development. Provides insight regarding current regulatory guidance on drug development such as gene therapy and rare diseases.
Author : Victor C. Beal
Publisher :
ISBN 13 :
Total Pages : 262 pages
Book Rating : 4.E/5 ( download)
Download or read book Regulatory Statistics written by Victor C. Beal and published by . This book was released on 1971 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1000710815
Total Pages : 298 pages
Book Rating : 4.0/5 (7 download)
Download or read book Innovative Statistics in Regulatory Science written by Shein-Chung Chow and published by CRC Press. This book was released on 2019-11-14 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Jerry Brito
Publisher : Mercatus Center at George Mason University
ISBN 13 : 0983607737
Total Pages : 128 pages
Book Rating : 4.9/5 (836 download)
Download or read book Regulation written by Jerry Brito and published by Mercatus Center at George Mason University. This book was released on 2012-08-13 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309222176
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)
Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Author : Manuel E. Pena-Rodriguez
Publisher : Quality Press
ISBN 13 : 1953079806
Total Pages : 205 pages
Book Rating : 4.9/5 (53 download)
Download or read book Statistical Process Control for the FDA-Regulated Industry written by Manuel E. Pena-Rodriguez and published by Quality Press. This book was released on 2013-04-14 with total page 205 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of this book is to understand and apply the different SPC tools in a company regulated by the Food and Drug Administration (FDA): those that manufacture pharmaceutical products, biologics, medical devices, food, cosmetics, and so on. The book is not intended to provide an intensive course in statistics; instead, it is intended to provide a how-to guide about the application of the diverse array of statistical tools available to analyze and improve the processes in an organization regulated by FDA. This book is aimed at engineers, scientists, analysts, technicians, managers, supervisors, and all other professionals responsible to measure and improve the quality of their processes. Although the examples and case studies presented throughout the book are based on situations found in an organization regulated by FDA, the book can also be used to understand the application of those tools in any type of industry. Readers will obtain a better understanding of some of the statistical tools available to control their processes and be encouraged to study, with a greater level of detail, each of the statistical tools presented throughout the book. The content of this book is the result of the author’s almost 20 years of experience in the application of statistics in various industries, and his combined educational background of engineering and law that he has used to provide consulting services to dozens of FDA-regulated organizations.
Author : Richard Kay
Publisher : John Wiley & Sons
ISBN 13 : 1119867401
Total Pages : 436 pages
Book Rating : 4.1/5 (198 download)
Download or read book Statistical Thinking for Non-Statisticians in Drug Regulation written by Richard Kay and published by John Wiley & Sons. This book was released on 2022-11-29 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: STATISTICAL THINKING FOR NON-STATISTICIANS IN DRUG REGULATION Statistical methods in the pharmaceutical industry are accepted as a key element in the design and analysis of clinical studies. Increasingly, the medical and scientific community are aligning with the regulatory authorities and recognizing that correct statistical methodology is essential as the basis for valid conclusions. In order for those correct and robust methods to be successfully employed there needs to be effective communication across disciplines at all stages of the planning, conducting, analyzing and reporting of clinical studies associated with the development and evaluation of new drugs and devices. Statistical Thinking for Non-Statisticians in Drug Regulation provides a comprehensive in-depth guide to statistical methodology for pharmaceutical industry professionals, including physicians, investigators, medical science liaisons, clinical research scientists, medical writers, regulatory personnel, statistical programmers, senior data managers and those working in pharmacovigilance. The author’s years of experience and up-to-date familiarity with pharmaceutical regulations and statistical practice within the wider clinical community make this an essential guide for the those working in and with the industry. The third edition of Statistical Thinking for Non-Statisticians in Drug Regulation includes: A detailed new chapter on Estimands in line with the 2019 Addendum to ICH E9 Major new sections on topics including Combining Hierarchical Testing and Alpha Adjustment, Biosimilars, Restricted Mean Survival Time, Composite Endpoints and Cumulative Incidence Functions, Adjusting for Cross-Over in Oncology, Inverse Propensity Score Weighting, and Network Meta-Analysis Updated coverage of many existing topics to reflect new and revised guidance from regulatory authorities and author experience Statistical Thinking for Non-Statisticians in Drug Regulation is a valuable guide for pharmaceutical and medical device industry professionals, as well as statisticians joining the pharmaceutical industry and students and teachers of drug development.
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 9264162151
Total Pages : 280 pages
Book Rating : 4.2/5 (641 download)
Download or read book Regulatory Impact Analysis Best Practices in OECD Countries written by OECD and published by OECD Publishing. This book was released on 1997-12-01 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first report to look across the OECD membership at how regulatory impact analysis is actually designed and carried out.
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 030945428X
Total Pages : 151 pages
Book Rating : 4.3/5 (94 download)
Download or read book Innovations in Federal Statistics written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-04-21 with total page 151 pages. Available in PDF, EPUB and Kindle. Book excerpt: Federal government statistics provide critical information to the country and serve a key role in a democracy. For decades, sample surveys with instruments carefully designed for particular data needs have been one of the primary methods for collecting data for federal statistics. However, the costs of conducting such surveys have been increasing while response rates have been declining, and many surveys are not able to fulfill growing demands for more timely information and for more detailed information at state and local levels. Innovations in Federal Statistics examines the opportunities and risks of using government administrative and private sector data sources to foster a paradigm shift in federal statistical programs that would combine diverse data sources in a secure manner to enhance federal statistics. This first publication of a two-part series discusses the challenges faced by the federal statistical system and the foundational elements needed for a new paradigm.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309172802
Total Pages : 88 pages
Book Rating : 4.3/5 (91 download)
Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.
Author : OECD
Publisher : OECD Publishing
ISBN 13 : 926416717X
Total Pages : 91 pages
Book Rating : 4.2/5 (641 download)
Download or read book Measuring Regulatory Performance A Practitioner's Guide to Perception Surveys written by OECD and published by OECD Publishing. This book was released on 2012-01-16 with total page 91 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guide helps officials use perception surveys for evaluating and communicating progress in regulatory reform. It explains the challenges involved in the design and use of business and citizen perception surveys – and ways to overcome them.
Author : Asli Demirguc-Kunt
Publisher : World Bank Publications
ISBN 13 : 1464812683
Total Pages : 228 pages
Book Rating : 4.4/5 (648 download)
Download or read book The Global Findex Database 2017 written by Asli Demirguc-Kunt and published by World Bank Publications. This book was released on 2018-04-19 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2011 the World Bank—with funding from the Bill and Melinda Gates Foundation—launched the Global Findex database, the world's most comprehensive data set on how adults save, borrow, make payments, and manage risk. Drawing on survey data collected in collaboration with Gallup, Inc., the Global Findex database covers more than 140 economies around the world. The initial survey round was followed by a second one in 2014 and by a third in 2017. Compiled using nationally representative surveys of more than 150,000 adults age 15 and above in over 140 economies, The Global Findex Database 2017: Measuring Financial Inclusion and the Fintech Revolution includes updated indicators on access to and use of formal and informal financial services. It has additional data on the use of financial technology (or fintech), including the use of mobile phones and the Internet to conduct financial transactions. The data reveal opportunities to expand access to financial services among people who do not have an account—the unbanked—as well as to promote greater use of digital financial services among those who do have an account. The Global Findex database has become a mainstay of global efforts to promote financial inclusion. In addition to being widely cited by scholars and development practitioners, Global Findex data are used to track progress toward the World Bank goal of Universal Financial Access by 2020 and the United Nations Sustainable Development Goals. The database, the full text of the report, and the underlying country-level data for all figures—along with the questionnaire, the survey methodology, and other relevant materials—are available at www.worldbank.org/globalfindex.
Author : Victor C. Beal
Publisher :
ISBN 13 :
Total Pages : 152 pages
Book Rating : 4.:/5 (319 download)
Download or read book Regulatory Statistics written by Victor C. Beal and published by . This book was released on 1983 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
